IFU is not found for this 510(k).
| 510(k) Number | Device Name | Applicant | Decision Date | Procode |
|---|---|---|---|---|
| K251596 | Lunderquist Extra Stiff Wire Guide |
William Cook Europe ApS | 11/09/2025 | DQX |
| K252564 | Medical Diode Laser Systems (VeinCure) |
Baoding Te'anzhou Electronic Technology Co., Ltd. |
11/07/2025 | GEX |
| K250264 | SugarBug (1.x) | Bench7 Inc. | 11/07/2025 | MYN |
| K251391 | BrainsWay Deep TMS System | BrainsWay Ltd. | 11/07/2025 | OBP |
| K250739 | Primeprint Direct Aligner | Dreve Dentamid GmbH | 11/07/2025 | NXC |
| K252519 | CO2 Laser Therapy System (K106) |
HEBEI KEYLASER SCI-TECH Co.,Ltd |
11/07/2025 | GEX |
| K252041 | Fibresolve (with PCCP) | Imvaria, Inc. | 11/07/2025 | QWO |
| K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System |
Inion Oy | 11/07/2025 | JEY |
| K253513 | MultiMatch Flow Chameleon AntiMicrobial Composite |
Premier Dental Products Company |
11/07/2025 | EBF |
| K250819 | Electric Wheelchair (Rollz Motion Electric 2M) |
Rollz International bv | 11/07/2025 | ITI |
| K251129 | S.I.N. Tapered Pro Conical Zygoma Implant System |
S.I.N. Implant System LTDA |
11/07/2025 | DZE |
| K251853 | Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
11/07/2025 | IYN |
| K243131 | Triathlon Pro | Sigma Biomedical | 11/07/2025 | NUH |
| K253039 | AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA |
Topcon Corporation | 11/07/2025 | HKX |
| K251295 | Ulrichinject CT Motion (XD 8000) |
ulrich GmbH & Co. KG | 11/07/2025 | IZQ |
| K252133 | Adaptix Ortho350 | Adaptix Limited | 11/06/2025 | IZF |
| K253265 | BriefCase-Triage | Aidoc Medical, Ltd. | 11/06/2025 | QAS |
| K252525 | AIO Breathe | AIOMEGA, LLC | 11/06/2025 | LRK |
| K252418 | Catalyst F1x Shoulder System | Catalyst OrthoScience, Inc. |
11/06/2025 | KWS |
| K252469 | MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA |
DMP Dental Industry S.A. | 11/06/2025 | KLE |
| K252515 | Q-Switched Nd:Yag Laser (K690) | HEBEI KEYLASER SCI-TECH Co.,Ltd |
11/06/2025 | GEX |
| K251004 | Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) |
Hefei Chimed Intelligent Machine Co., Ltd |
11/06/2025 | OXO |
| K250815 | Hubly Drill (H100) | Hubly, Inc. | 11/06/2025 | HBE |
| K250423 | Mb-fix Cranial Stabilization Systems |
Medical Bees GmbH | 11/06/2025 | HBL |
| K253478 | Motive™ Muscle Stimulator For Lower Back (OT01-1003) |
Motive Health Inc. | 11/06/2025 | |
| K251555 | Ultra™ Compression Screw System |
Pace Surgical | 11/06/2025 | HWC |
| K251792 | GenesisX RMN® (Robotic Magnetic Navigation) System With Navigant®™ Workstation (NWS) And Cardiodrive® (001-014000-1) |
Stereotaxis, Inc. | 11/06/2025 | DXX |
| K253074 | Tandem Mobi Insulin Pump With Interoperable Technology |
Tandem Diabetes Care, Inc. |
11/06/2025 | QFG |
| K252845 | Venus Nova (FP-2001) | Venus Concept Inc. | 11/06/2025 | GEI |
| K250363 | Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); Dept |
Beijing Sinovation Medical Technology Co., Ltd. |
11/05/2025 | GZL |
| K250599 | ExcelsiusGPS™ Instruments | Globus Medical, Inc. | 11/05/2025 | OLO |
| K252514 | EVAC-MRI | Phasor Health, LLC | 11/05/2025 | JXG |
| K252677 | Polyshield Safety IV Catheters | Poly Medicure Limited | 11/05/2025 | FOZ |
| K250376 | ViVY | ViaTherm Therapeutics, LLC |
11/05/2025 | IMJ |
| K250375 | Allure Hip Stem And Intramedullary Plugs |
Waldemar Link GmbH & Co. KG |
11/05/2025 | MEH |
| K252740 | Voyant® Open Fusion Device (EB240/Open Fusion) |
Applied Medical Resources Corp. |
11/04/2025 | GEI |
| K252664 | GMReis Suture Anchors | GM Dos Reis Industria e Comercio Ltda. |
11/04/2025 | MBI |
| K250576 | Flexx Junior (FLX-J00, FLX-J50) |
KARMA MOBILITY CO LTD | 11/04/2025 | IOR |
| K251709 | MedCAD® AccuStride™ System | MedCAD | 11/04/2025 | PBF |
| K251303 | Tamburo Thulium Fiber Laser System |
menovex Medical Technology (Shenzhen) Co., Ltd |
11/04/2025 | GEX |
| K250853 | Merit Syringe | Merit Medical Systems, Inc. |
11/04/2025 | FMF |
| K252964 | PRIMED Surgical And Procedure Masks |
PRIMED Medical Products Inc. |
11/04/2025 | FXX |
| K250241 | Cios Select | Siemens Medical Solutions USA, Inc |
11/04/2025 | OWB |
| K251410 | VXvue | Vieworks Co., Ltd. | 11/04/2025 | LLZ |
| K253448 | Sonosite MT Ultrasound System | FUJIFILM Sonosite, Inc. | 11/03/2025 | IYN |
| K252671 | Electric Wheelchair (NSDS-01) | Hebei Dansong Medical Technology Co., Ltd. |
11/03/2025 | ITI |
| K251626 | Midmark Dental Delivery System | Midmark Corporation | 11/03/2025 | EIA |
| K251532 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) |
Mighty Oak Medical | 11/03/2025 | LLZ |
| K252698 | NightGuard Aire Max | Nightguard Express, LLC | 11/03/2025 | LRK |
| K250330 | 3mensio Workstation | Pie Medical Imaging B.V. | 11/03/2025 | QIH |
| K252481 | Cobas CMV | Roche Molecular Systems, Inc. |
11/03/2025 | PAB |
| K252484 | Cobas HCV | Roche Molecular Systems, Inc. |
11/03/2025 | MZP |
| K252458 | Kyphoplasty Balloon Dilatation Catheters |
Shanghai Lange MedTech Co., Ltd |
11/03/2025 | HRX |
| K250392 | ZAP-X Radiosurgery System (ZAP-X) |
Zap Surgical Systems, Inc. |
11/03/2025 | |
| K250358 | BD Enteric Bacterial Panel For BD COR System, BD Enteric Bacterial Panel Plus For BD COR System, And Enteric Bacterial Panel Diluent For BD COR System |
Becton, Dickinson and Company |
10/31/2025 | PCI |
| K253501 | Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204); |
Vigodent Indústria e Comercio Ltda |
10/31/2025 | ELW |
| K251547 | DESS Dental Smart Solutions | Terrats Medical SL | 10/31/2025 | NHA |
| K250917 | Flexible Ureterorenoscope System (Electronic Endoscope Image Processor, Model: SP-TXCLQ12.1, Flexible Ureterorenoscope, Model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8) |
Shenzhen Sanping Image Technology Co., Ltd. |
10/31/2025 | FGB |
| K252427 | Diode Laser Hair Removal Machine (GLD01) |
Sanhe Meditech Co.,Ltd | 10/31/2025 | GEX |
| K250306 | Chex-All Sterilization Pouches And Tubes |
Propper Manufacturing Co, Inc. |
10/31/2025 | FRG |
| K252060 | GREEN | Phasor Health, LLC | 10/31/2025 | HBE |
| K252160 | Persyst 15 EEG Review And Analysis Software (Persyst 15 (P15)) |
Persyst Development LLC | 10/31/2025 | OMB |
| K252088 | Firebird SI Navigation System | Orthofix US LLC | 10/31/2025 | OLO |
| K250338 | MSS - Humeral Reverse Liners Extension |
Medacta International S.A. |
10/31/2025 | PHX |
| K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones) |
Maxx Orthopedics, Inc. | 10/31/2025 | MBH |
| K251381 | Ceribell Instant EEG Headcap (Small: C251, Medium: C252) |
Ceribell, Inc. | 10/31/2025 | GXY |
| K252074 | Aplio I900, Aplio I800 And Aplio I700 Software V9.0 Diagnostic Ultrasound System |
Canon Medical Systems Corporation |
10/31/2025 | IYN |
| K252412 | Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) |
Applied Medical Resources Corporation |
10/31/2025 | GEI |
| K252442 | Kii Structural Balloon Access System |
Applied Medical Resources Corp. |
10/31/2025 | GCJ |
| K251041 | GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 |
Actuated Medical, Inc. | 10/31/2025 | FDS |
| K252387 | Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) |
Diasorin Molecular, LLC | 10/30/2025 | QOF |
| K252607 | AllTest Urinary Tract Infection Test |
Hangzhou Alltest Biotech Co.,Ltd |
10/30/2025 | JMT |
| K250337 | AiORTA - Plan | ViTAA Medical Solutions Inc. |
10/30/2025 | QIH |
| K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max) |
Tornier, Inc. | 10/30/2025 | KWT |
| K243619 | Niti-S Esophageal Stent; Esophageal TTS Stent |
Taewoong Medical Co., Ltd. |
10/30/2025 | ESW |
| K252414 | Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) |
Shenzhen Kaiyan Medical Equipment Co., Ltd |
10/30/2025 | OAP |
| K251938 | GEN5 And GEN5+ Dental Implant System |
Paragon Implant Mfg., LLC |
10/30/2025 | DZE |
| K251531 | AIR COMPRESSION BOOTS 1018195,1018196 |
Merchsource LLC | 10/30/2025 | IRP |
| K253327 | HANAROSTENT Esophagus Upper (CCC) |
M.I. Tech Co., Ltd. | 10/30/2025 | ESW |
| K252046 | Zoom System (Zoom 4S Catheter) | Imperative Care, Inc. | 10/30/2025 | NRY |
| K252430 | Freeprint® Denture Flex | detax GmbH | 10/30/2025 | EBI |
| K252752 | Ellacor System With Micro-Coring Technology |
Cytrellis Biosystems, Inc. |
10/30/2025 | QAI |
| K250325 | BD Alaris Pump Infusion Set | CareFusion (BD) | 10/30/2025 | FPA |
| K253376 | OBSIDIO™ Conformable Embolic (M0013972101010) |
Boston Scientific Corporation |
10/30/2025 | KRD |
| K252529 | Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110); Moses™ 550 D/F/L Laser Fiber (M0068130120) |
Boston Scientific Corporation |
10/30/2025 | GEX |
| K250632 | Arctx Cool Catheter Set | Arctx Medical | 10/30/2025 | PLA |
| K252393 | VITROS Immunodiagnostic Products Hs Troponin I Reagent Pack |
Ortho-Clinical Diagnostics, Inc. |
10/29/2025 | MMI |
| K250618 | Medi Lift Essential Eye Mask | YA-MAN Ltd. | 10/29/2025 | NFO |
| K251643 | Synchfix EVT | Wright Medical Technology, Inc (Stryker Corporation) |
10/29/2025 | HTN |
| K253153 | SER Pen Carain MicroSystem (MP1209SP) |
Su-Ko Technologies LLC | 10/29/2025 | QAI |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0 |
Smith & Nephew, Inc. | 10/29/2025 | KWS |
| K253283 | Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) |
Shenzhen Root Innovation Technology Co., Ltd. |
10/29/2025 | HGX |
| K253242 | LCD Monitor (C1216W, C822W, C821W) |
Shenzhen Beacon Display Technology Co., Ltd. |
10/29/2025 | PGY |
| K251772 | Navilas Laser System 577sl (156691) |
OD-OS GmbH | 10/29/2025 | HQF |
| K250316 | Meduloc Intramedullary Fracture Fixation (IFF) System |
Meduloc, LLC | 10/29/2025 | JDW |
| K252390 | Telescope Guide Extension Catheter |
Medtronic Ireland | 10/29/2025 | DQY |
| K253314 | Freedom Infinia™ Total Knee System |
Maxx Orthopedics Inc. | 10/29/2025 | JWH |
| K253323 | Protrieve Sheath | Inari Medical | 10/29/2025 | QEW |
| K250882 | SANSA HSAT | Huxley Medical | 10/29/2025 | MNR |
| K252697 | 3D Laparoscope | Guangdong OptoMedic Technologies, Inc. |
10/29/2025 | GCJ |
| K251963 | LOGIQ E10s | GE Medical Systems Ultrasound and Primary care Diagnostics, |
10/29/2025 | IYN |
| K251985 | LOGIQ E10 | GE Medical Systems Ultrasound and Primary Care Diagnostics |
10/29/2025 | IYN |
| K253355 | Difiney Advanced Anti Snoring Device 4.0 |
Fissiontech LLC | 10/29/2025 | LRK |
| K253345 | JARVIS Diaphyseal Stem Standard |
FH Industrie | 10/29/2025 | PHX |
| K252314 | Arthrex SutureTak Suture Anchor |
Arthrex, Inc. | 10/29/2025 | MBI |
| K253232 | Seguin Annuloplasty Ring | Abbott Medical | 10/29/2025 | KRH |
| K251466 | VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf Garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf Garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf Garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh Garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh Garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh Garment (L)); VenAir, Sequential Compr |
Wellell Inc. | 10/28/2025 | JOW |
| K253399 | Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter |
Volcano Corporation (dba Philips Image Guided Therapy Device |
10/28/2025 | OBJ |
| K252742 | Navigated Instruments | Tyber Medical, LLC | 10/28/2025 | OLO |
| K252165 | ZIRCONOMER P | Shofu Dental Corporation | 10/28/2025 | EMA |
| K252376 | Yomi S Robotic System | Neocis, Inc. | 10/28/2025 | PLV |
| K252351 | UniSpace® TPLIF Cage | CG MedTech Co., Ltd. | 10/28/2025 | MAX |
| K252547 | TheraSphere 360™ Y-90 Management Platform |
Boston Scientific Corporation |
10/28/2025 | LLZ |
| K253300 | Fine Osteotomy™ | Bodycad Laboratories Inc. |
10/28/2025 | HRS |
| K250275 | PrecisePath™ Radiofrequency Puncture Generator And PrecisePath™ Footswitch |
Baylis Medical Technologies Inc. |
10/28/2025 | GEI |
| K252467 | Disposable Vinyl Examination Gloves |
Viet Phu Trade and Import Export Co., Ltd |
10/27/2025 | LYZ |
| K252053 | VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F) |
TOUCHBEAUTY BEAUTY & HEALTH ( SHENZHEN ) CO., LTD | 10/27/2025 | OHS |
| K250297 | TECHFIT Patient-Specific Cranial System |
TECHFIT Digital Surgery Inc. |
10/27/2025 | GWO |
| K251331 | Blood Pressure Monitor (B73, BE23T) |
Shenzhen Jamr Technology Co., Ltd. |
10/27/2025 | DXN |
| K251824 | Patriot Duo | Patriot Laser, LLC | 10/27/2025 | GEX |
| K250520 | OsteoCentric Navigated Instruments System |
OsteoCentric Technologies, Inc. |
10/27/2025 | OLO |
| K252630 | Electric Breast Pump (HL-3060, F5113) |
Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd |
10/27/2025 | HGX |
| K252629 | Electric Breast Pump (HL-3058, F5112) |
Fimilla (Shanghai) maternity & baby Articles Co., Ltd |
10/27/2025 | HGX |
| K251027 | Cvi42 Coronary Plaque Software Application |
Circle Cardiovascular Imaging Inc. |
10/27/2025 | QIH |
| K251875 | LifeScale Gram Negative Kit (LSGN) With The LifeScale AST System |
Affinity Biosensors, LLC | 10/27/2025 | SAN |
| K253106 | AngioVac Cannula | AngioDynamics, Inc. | 10/24/2025 | DWF |
| K252730 | Fule Spinal Fixation System | Beijing Fule Science & Technology Development Co., Ltd. |
10/24/2025 | NKB |
| K252238 | CoroFlow Cardiovascular System | Coroventis Research AB | 10/24/2025 | DQK |
| K250687 | Cocoon Solo (DX-7020s) | Dexcowin Global Inc | 10/24/2025 | MUH |
| K251784 | Hushd Pro Z-Link | Good Sleep Co Pte Ltd. | 10/24/2025 | LRK |
| K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral Components |
Howmedica Osteonics Corp. dba Stryker Orthopaedics |
10/24/2025 | MBH |
| K253150 | Cryon-X Cold Compression | JKH Health Co., Ltd. | 10/24/2025 | IRP |
| K250696 | AccuCheck | Manteia Technologies Co., Ltd. |
10/24/2025 | IYE |
| K251974 | Arctic Sun Temperature Management System (Model 5000) |
Medivance, Inc. | 10/24/2025 | DWJ |
| K250345 | Medline Bag Decanter | Medline Industries, LP. | 10/24/2025 | LHI |
| K253125 | Parietene™ Flat Sheet Mesh | Medtronic - Sofradim Production |
10/24/2025 | FTL |
| K253129 | Infinity™ OCT System | Medtronic Sofamor Danek USA, Inc. |
10/24/2025 | NKG |
| K253335 | CD Horizon™ Spinal System | Medtronic Sofamor Danek USA, Inc. |
10/24/2025 | NKB |
| K252646 | Single-Use Fine Needle Biopsy (FNB) Device (NA-U210H) |
Olympus Medical Systems Corp. |
10/24/2025 | FCG |
| K251827 | Azurion R3.1 | Philips Medical Systems B.V. |
10/24/2025 | OWB |
| K252645 | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub |
Philips Medical Systems Nederland B.V. |
10/24/2025 | DQK |
| K251059 | Syngo Carbon Clinicals (VA41) | Siemens Healthineers AG | 10/24/2025 | QIH |
| K251710 | Mobile X-ray Unit (!M1) | Solutions for tomorrow AB |
10/24/2025 | IZL |
| K253377 | Expandable Titanium PLIF/TLIF System |
Spectrum Spine, Inc. | 10/24/2025 | MAX |
| K251372 | VersaD Delivery Catheter | Unity Medical, Inc | 10/24/2025 | QJP |
| K251312 | Vesalio Peripheral System | Vesalio Inc. | 10/24/2025 | QEZ |
| K250904 | Atalante X | Wandercraft SAS | 10/24/2025 | PHL |
| K253188 | CoaguChek XS Plus System | Roche Diagnostics | 10/24/2025 | GJS |
| K252357 | Glucose2 | Abbott Ireland | 10/24/2025 | CFR |
| K252931 | Invisalign® Palatal Expander System |
Align Technology, Inc | 10/23/2025 | NXC |
| K253100 | MultiPulse TFL | Asclepion Laser Technologies GmbH |
10/23/2025 | GEX |
| K250861 | Nitrile Powder Free Examination Glove Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid And Fentanyl In Simulated Gastric Acid (Black) |
Hartalega NGC Sdn. Bhd. | 10/23/2025 | LZA |
| K252345 | Picosecond Laser Device (PF131-BI) |
RiSu Medical Technology Co., Ltd. |
10/23/2025 | GEX |
| K252425 | Silatrix Oral Gel | SA3, LLC | 10/23/2025 | OLR |
| K250288 | TeraRecon Cardiovascular.Calcification.C T |
TeraRecon, Inc. | 10/23/2025 | QIH |
| K252384 | DESS® Dental Smart Solutions | Terrats Medical SL | 10/23/2025 | NHA |
| K253226 | UV5000W Handle | UroViu Corporation | 10/23/2025 | FAJ |
| K252309 | PerQseal Introducers | Vivasure Medical Limited | 10/23/2025 | DYB |
| K252732 | 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) |
Zhengzhou PZ Laser Slim Technology Co., Ltd |
10/23/2025 | GEX |
| K252569 | Carrier XL Delivery Catheter | Balt USA, LLC | 10/22/2025 | QJP |
| K252325 | Hair Growth Laser Cap | Cosmo Far East Technology Limited |
10/22/2025 | OAP |
| K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) |
Datex-Ohmeda. Inc. | 10/22/2025 | FMZ |
| K251628 | Mandibular Advancement Device L07 |
DCSTAR INC | 10/22/2025 | LRK |
| K252322 | SIros-X System | Genesys Spine | 10/22/2025 | OUR |
| K252298 | ANDI 2.0 | Imeka Solutions Inc. | 10/22/2025 | QIH |
| K251185 | Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) |
Intervene | 10/22/2025 | QEW |
| K253144 | Freedom® Total Knee System – Titan PCK Components |
Maxx Orthopedics Inc. | 10/22/2025 | JWH |
| K251977 | Electric Breast Pump (FZ-P8); Electric Breast Pump (YH-P8); Electric Breast Pump (YH-P8X) |
Ningbo Youhe Electrical Appliance Technology Co., Ltd |
10/22/2025 | HGX |
| K253147 | FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft Substitute |
Prosidyan, Inc. | 10/22/2025 | MQV |
| K253145 | Pre-Sutured Tendon | RTI Surgical, Inc. | 10/22/2025 | GAT |
| K251030 | Sirona Advanced Imaging Suite | Sirona Medical | 10/22/2025 | LLZ |
| K250955 | XC11 ICE System, USA | Yorlabs, Inc. | 10/22/2025 | OBJ |
| K250666 | Alegria Flash CTD Screen | ZEUS Scientific | 10/22/2025 | LLL |
| K252329 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V QIAstat-Dx GI Panel 2 Mini B |
QIAGEN GmbH | 10/22/2025 | PCH |
| K251289 | WELLlife COVID-19 Antigen Test Rx |
Guangzhou Wondfo Biotech Co., Ltd. |
10/22/2025 | QVF |
| K251749 | Flowflex Plus RSV + Flu A/B + COVID Home Test |
ACON Laboratories, Inc. | 10/22/2025 | SCA |
| K253040 | Aevumed FASE Suture Anchor | Aevumed, Inc. | 10/21/2025 | MBI |
| K252346 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System |
Astura Medical | 10/21/2025 | NKB |
| K250394 | Fine TTO™ | Bodycad Laboratories Inc. |
10/21/2025 | PBF |
| K251838 | Introducer Sheath Set | Cardiocycle Medical (Suzhou) Co.,Ltd |
10/21/2025 | DYB |
| K253034 | HemoSphere Stream Module | Edwards Lifesciences | 10/21/2025 | DQK |
| K250126 | ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) |
LivsMed Inc. | 10/21/2025 | GEI |
| K231897 | NeuroAlign Software | Medivis, Inc. | 10/21/2025 | HAW |
| K253249 | TriALTIS™ Spine System | Medos International SARL | 10/21/2025 | NKB |
| K250887 | Neuromuscular Transmission Monitor TOF3D (2510091) |
MIPM Mammendorfer Institut für Physik und Medizin GmbH |
10/21/2025 | KOI |
| K250409 | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA) |
Olympus Medical Systems Corporation |
10/21/2025 | FGE |
| K253033 | Chemfort® 28-day 20 Mm Vial Adaptor And 13 Mm Convertor |
Simplivia Healthcare Ltd. |
10/21/2025 | ONB |
| K252665 | Brain™ Shoulder Positioning | Avatar Medical | 10/20/2025 | QIH |
| K252155 | AVAVA™ Skin Treatment System | Avava Inc. | 10/20/2025 | ONG |
| K251414 | Miracu™ Polydioxanone (PDO) Suture And Needle (MONO) |
Feeltech Co., Ltd. | 10/20/2025 | NEW |
| K252640 | VereSee Optical Veres Needle And Endoscopic Camera |
Freyja Healthcare, LLC | 10/20/2025 | GCJ |
| K253182 | InkSpace Imaging Small Body Array (SBA12PH30x) |
InkSpace Imaging, Inc. | 10/20/2025 | MOS |
| K252319 | Q-Switched Nd: YAG Laser Machine (LFS-C13U) |
Sanhe LEFIS Electronics Co., Ltd. |
10/20/2025 | GEX |
| K252277 | Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645) |
Vascular Flow Technologies Limited |
10/20/2025 | DSY |
| K242827 | A8 INTEGR8™ Porous Pedicle Screws |
ALLUMIN8, Inc. | 10/20/2025 | NKB |
| K250178 | Adin Customized Abutments | Adin Dental Implant Systems Ltd. |
10/17/2025 | NHA |
| K250197 | Estremo Fibular Nail | Citieffe s.r.l. | 10/17/2025 | HSB |
| K250911 | MOSkin Radiation Measurement System |
Electrogenics Labs, Ltd | 10/17/2025 | IYE |
| K250145 | Biopsy Port Adapter | EndoSound, Inc. | 10/17/2025 | ODC |
| K251282 | StealthStation S8 Spine Software |
Medtronic Navigation, Inc. |
10/17/2025 | OLO |
| K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) |
Olympus Medical Systems Corp. |
10/17/2025 | KNS |
| K251146 | IntelliVue Patient Monitors MX400, MX450, MX500, MX550 |
Philips Medizin Systeme Boeblingen GmbH |
10/17/2025 | MHX |
| K252075 | Program Insite® Powder-Free, Disposable Nitrile Exam Gloves |
Program insite LLC | 10/17/2025 | LZA |
| K251778 | Remi Custom Night Guard | Remi | 10/17/2025 | OBR |
| K252266 | S.I.N. Dental Implant System | S.I.N. Implant System LTDA. |
10/17/2025 | NHA |
| K250227 | JOVS Electric Stimulation Beauty Device (JE2) |
Shenzhen Qianyu Technology Co., Ltd. |
10/17/2025 | NFO |
| K252264 | MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10) |
Shenzhen Zhenxing Ruitong Technology Co., Ltd. |
10/17/2025 | OHS |
| K252254 | Osteotomy Wedge System | SiNAPTIC Surgical | 10/17/2025 | PLF |
| K251355 | X1-FFR | SpectraWAVE, Inc. | 10/17/2025 | QHA |
| K251832 | InZone IST Detachment System; IZDS Connecting Cable |
Stryker Neurovascular | 10/17/2025 | HCG |
| K250203 | SureAx-Guide™ | SureAx Medical, LLC | 10/17/2025 | DQX |
| K251673 | X9 Ultrasound System | X9, Inc. | 10/17/2025 | SGH |
| K250159 | Immunoglobulin Isotypes (GAM) For The EXENT Analyser; EXENT Analyser |
The Binding Site Group Ltd |
10/17/2025 | SGG |
| K250250 | ADVIA Centaur Anti-Thyroid Peroxidase II |
Siemens Healthcare Diagnostics, Inc. |
10/17/2025 | JZO |
| K251994 | Arthrex Synergy Vision Imaging System |
Arthrex, Inc. | 10/16/2025 | GCJ |
| K250852 | Coolfase | ASTERASYS Co., Ltd. | 10/16/2025 | GEI |
| K252476 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout |
Brainlab AG | 10/16/2025 | LLZ |
| K252631 | Profoject™ Disposable Needle | CMT Health PTE. Ltd. | 10/16/2025 | FMI |
| K253000 | CryoFreeze Wart And Skin Tag Remover |
CryoSurgery, Inc. | 10/16/2025 | GEH |
| K251497 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | 10/16/2025 | NHA |
| K251882 | Uterine Aspiration Set | GCMEDICA ENTERPRISE LTD.(WUXI) |
10/16/2025 | HHK |
| K250731 | MateLaser Medical Diode Laser Systems (ML-DLS-30) |
MateLaser, Inc. | 10/16/2025 | NVK |
| K242100 | SurgiAid Collagen Wound Dressing (HA) |
Maxigen Biotech Inc. | 10/16/2025 | KGN |
| K252093 | Light Therapy Mask (1019055) | Merchsource LLC | 10/16/2025 | OHS |
| K243727 | Re:Balans | Mode Sensors AS | 10/16/2025 | DSB |
| K252024 | NeurAxis IB-Stim (01-1020) | NeurAxis | 10/16/2025 | QHH |
| K252247 | Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L) |
Olympus Medical Systems Corporation |
10/16/2025 | FBK |
| K252612 | INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing |
Penumbra, Inc. | 10/16/2025 | QEW |
| K253114 | TargetCool™ (RM-DT02W) | RecensMedical Inc. | 10/16/2025 | GEH |
| K253024 | ProZip Knotless Implant | Riverpoint Medical | 10/16/2025 | GAT |
| K252153 | FFX Facet Fixation System | SC Medica | 10/16/2025 | MRW |
| K252223 | Alpha Endo Handpiece (Alpha Endo) |
Shenzhen Superline Technology Co., Ltd. |
10/16/2025 | EKX |
| K252199 | AGFA HealthCare Enterprise Imaging |
AGFA HealthCare N.V. | 10/15/2025 | LLZ |
| K252946 | BioBrace® Extra-Articular Ligament Augmentation Kit |
CONMED Corporation | 10/15/2025 | MAI |
| K250107 | V-soft Line™ Barbed Surgical Suture (Various) |
Feeltech Co., Ltd | 10/15/2025 | NEW |
| K252020 | TunnelVision Endoscopic Soft Tissue Release System And The HBL Blade Assembly |
Hand Biomechanics Lab, Inc. |
10/15/2025 | |
| K252367 | InbellaMulti System | Inbella Medical Inc. | 10/15/2025 | GEI |
| K252920 | ELEOS™ Limb Salvage System With NanoCept® Technology |
Onkos Surgical, Inc. | 10/15/2025 | QZZ |
| K253348 | TargetCool-e | RecensMedical, Inc. | 10/15/2025 | GEH |
| K250510 | Sure-Fine Insulin Syringes | SHINA MED CORPORATION | 10/15/2025 | FMF |
| K251805 | Syngo.ct Dual Energy | Siemens Medical Solutions USA, Inc. |
10/15/2025 | JAK |
| K251294 | Bonafix Implant Abutments | Zentek Medical LLC | 10/15/2025 | NHA |
| K252944 | LOCATOR® Angled Abutment | Zest Anchors, LLC | 10/15/2025 | NHA |
| K250979 | Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad) |
ZOLL Circulation, Inc | 10/15/2025 | NZE |
| K251715 | FlowArt® Vial Access Device Vented |
Asset Medikal | 10/14/2025 | LHI |
| K250776 | Lithoblast Single Use Holmium Laser Fibers |
Dawell Medical LLC. | 10/14/2025 | GEX |
| K252637 | Community Containers (Flap And Daisy) |
Keter Canada, Inc. | 10/14/2025 | MMK |
| K253461 | Demi Pro | Meta Systems Co., Ltd. | 10/14/2025 | EBZ |
| K253331 | PressON Spinal Fixation System | Nexus Spine | 10/14/2025 | NKB |
| K253099 | LIFEPAK 15 AC Power Adapter (41577-000333) |
Physio-Control, Inc. | 10/14/2025 | MPD |
| K251874 | PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) |
PureWay Compliance Inc. | 10/14/2025 | MMK |
| K250115 | Hemastyl(™) Wound Dressing | Rapid Nexus Nanotech Wound Solutions, Inc. |
10/14/2025 | FRO |
| K253010 | Mini Superhawk Suture Anchor System |
Responsive Arthroscopy, LLC |
10/14/2025 | MBI |
| K252234 | IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16, FDA17, FDA18, FDA19, FDA20, FDA21S, FDA22S, FDA23S, FDA24S, FDA25, FDA26, FDA27, FDA28, FDA29S, FDA30S, FDA31S) |
Shenzhen Qiaochengli Technology Co., Ltd |
10/14/2025 | OHT |
| K251522 | Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ |
Bone Solutions, Inc. | 10/13/2025 | MQV |
| K251595 | COVID-19 Detect Rapid Self -Test |
InBios International, Inc. |
10/12/2025 | QYT |
| K242227 | GENEO X ELITE | Pollogen, Ltd. | 10/12/2025 | PAY |
| K251034 | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44) |
Shenzhen Nuon Medical Equipment Co., Ltd |
10/12/2025 | NFO |
| K251602 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 With Aevolve Imaging |
Canon Medical Systems Corporation |
10/10/2025 | OWB |
| K252903 | Verruca-Freeze H Plus | CryoSurgery, Inc. | 10/10/2025 | GEH |
| K252737 | DeGen Medical Latitude-C AM Cervical Interbody Fusion System |
DeGen Medical | 10/10/2025 | ODP |
| K252312 | Eleganz IM Threaded Nail System (IM Threaded Nail System) |
Dev4 | 10/10/2025 | HWC |
| K251708 | EvoEndo Single-Use Endoscopy System |
EvoEndo, Inc. | 10/10/2025 | FDS |
| K252209 | IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032) |
Foshan Jindi Electric Appliance Co., Ltd |
10/10/2025 | OHT |
| K250249 | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System |
Gold Standard Diagnostics, LLC. |
10/10/2025 | GMQ |
| K251835 | Yomi Robotic System | Neocis, Inc. | 10/10/2025 | PLV |
| K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) |
Olympus Medical Systems Corporation |
10/10/2025 | KNS |
| K243078 | HexaPLUS S OneDrill Implant System |
Osseofuse International Inc. |
10/10/2025 | DZE |
| K251082 | HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) |
Procept BioRobotics | 10/10/2025 | PZP |
| K243815 | SoClean 3+ | SoClean, Inc. | 10/10/2025 | QXQ |
| K251866 | Tegaderm Post-Op Transparent Antimicrobial Dressing |
Solventum US, LLC | 10/10/2025 | FRO |
| K252544 | TMINI Miniature Robotic System | Think Surgical, Inc. | 10/10/2025 | OLO |
| K252001 | Collagen Wound Dressing | Winner Medical Co., Ltd. | 10/10/2025 | KGN |
| K251927 | Zeta Navigation System (ZNS131-US) |
Zeta Surgical Inc. | 10/10/2025 | SGE |
| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System |
ACON Laboratories, Inc. | 10/10/2025 | NBW |
| K252870 | Invisalign Specifix Attachment System |
Align Technology, Inc. | 10/09/2025 | NXC |
| K252910 | Orca Air/Water And Suction Valves |
Boston Scientific | 10/09/2025 | ODC |
| K252939 | COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS |
Cotton High Tech S.L. | 10/09/2025 | HEB |
| K251851 | DIASAFEplusUS (F00013010) | Fresenius Medical Care Renal Therapies Group, LLC |
10/09/2025 | FIP |
| K250645 | SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) |
Haemoband Surgical LTD | 10/09/2025 | FER |
| K251795 | Wrist Automatic Blood Pressure Monitor (LD-735, LD-752, LD-753) |
HONSUN (Nantong) Co.,Ltd. |
10/09/2025 | DXN |
| K252911 | Lux HD 2530 Detector (Lux HD 2530) |
iRay Imaging Technology (Haining) Limited |
10/09/2025 | MQB |
| K251366 | EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) |
Nihon Kohden Corporation | 10/09/2025 | OLT |
| K251876 | Cleadew GP Hydra One | Ophtecs Corporation | 10/09/2025 | MRC |
| K252600 | Pediatric Plating Platform I Small-Mini |
OrthoPediatrics Corp. | 10/09/2025 | HRS |
| K251651 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System |
Philips Ultrasound LLC | 10/09/2025 | IYN |
| K252553 | Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) |
Shenzhen Jianchao Intelligent Technology Co., LTD |
10/09/2025 | NFO |
| K252272 | ORA Method LED Gua Sha (GS-04) | Shenzhen Kaiyan Medical Equipment Co., Ltd |
10/09/2025 | OHS |
| K253094 | Ifuse Bedrock Granite Implant System |
SI-Bone, Inc. | 10/09/2025 | OUR |
| K252867 | VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup |
Advin Biotech, Inc. | 10/09/2025 | NFT |
| K252766 | 14Fr Low Profile Introducer Kit |
Abiomed Inc. | 10/08/2025 | DYB |
| K251422 | BD Saf-T-Intima™ Subcutaneous Catheter System |
Becton Dickinson Infusion Therapy Systems Inc. |
10/08/2025 | FOZ |
| K251699 | The Botticelli (Model: Athena) | Bellamia Technologies, Inc. |
10/08/2025 | GEX |
| K250298 | Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® With Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® For Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S) |
Clinical Innovations, LLC |
10/08/2025 | HDB |
| K251363 | ProKnow DS | Elekta Solutions AB | 10/08/2025 | LLZ |
| K250536 | MetaFore Small Screw System | Extremity Medical, LLC | 10/08/2025 | HWC |
| K250060 | GT300; GT300-C | GENORAY CO., LTD. | 10/08/2025 | OAS |
| K251162 | CUSA® Clarity Ultrasonic Surgical Aspirator System |
Integra LifeSciences Corporation |
10/08/2025 | LFL |
| K252874 | Compass Steerable Needle With Adapters SRA-1-01 And SRA-2-01 |
Serpex Medical, Inc. | 10/08/2025 | KTI |
| K252163 | Elecsys Phospho-Tau (181P) Plasma |
Roche Diagnostics | 10/08/2025 | SET |
| K250688 | Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US) |
Acotec Scientific Co., Ltd. |
10/07/2025 | GEI |
| K252851 | Deeplive (OSP12 + DMS) | DAMAE Medical | 10/07/2025 | NQQ |
| K250894 | Eminent Spine Posterior SI System |
Eminent Spine | 10/07/2025 | OUR |
| K252214 | AIAS Cephalon | metamorphosis GmbH | 10/07/2025 | QIH |
| K250187 | Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) |
Olympus Medical Systems Corporation |
10/07/2025 | KGE |
| K252150 | Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears With Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears With Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears With Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears With Ultrasonic Mode, 5mm, 20cm (TB2-0520FC) |
Olympus Medical Systems Corporation |
10/07/2025 | GEI |
| K252572 | Prodeon Urethral Sheath System | Prodeon Medical, Inc. | 10/07/2025 | FED |
| K250364 | Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV Toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV Multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens |
St. shine Optical Co., Ltd. |
10/07/2025 | LPL |
| K252948 | TrueBeam, TrueBeam STX, Edge And VitalBeam |
Varian Medical Systems, Inc. |
10/07/2025 | IYE |
| K244041 | Ultrasound Therapy Workstation (XMS-UET2) |
Xemis Medical Technology (Shenzhen) Co., Ltd. |
10/07/2025 | IMG |
| K252140 | Heylo™ System | Coloplast Corp | 10/06/2025 | EXB |
| K250173 | Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube With TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube With TaperGuard™ Cuff, Murphy Eye (119-XXNR) |
Covidien LLC | 10/06/2025 | BTR |
| K252007 | BlineSlide | Deep Breathe Inc. | 10/06/2025 | QIH |
| K252502 | Folding Mobility Scooter (KD101) |
Nanjing Kangni Smart Technology Co.,Ltd. |
10/06/2025 | INI |
| K251603 | Tigertriever 17 Ultra Revascularization Device |
Rapid Medical Ltd. | 10/06/2025 | NRY |
| K251565 | Wheelchair (N817) | ZHEJIANG TOPWE TOOLS MANUFACTURING CO.,LTD |
10/06/2025 | ITI |
| K250031 | Amplatzer Guidewire | Abbott Medical | 10/03/2025 | DQX |
| K251646 | Extricare® 1000 Negative Pressure Wound Therapy System |
Alleva Medical Devices | 10/03/2025 | OMP |
| K251639 | Xvision Spine System | Augmedics Ltd. | 10/03/2025 | SBF |
| K250662 | Bunkerhill MAC | BunkerHill Health | 10/03/2025 | JAK |
| K250028 | Anti Snore Mouthpiece | Dongguan Yiyao Science & Technology Development Co., Ltd. |
10/03/2025 | LRK |
| K250039 | HPACS | HealthHub | 10/03/2025 | LLZ |
| K251468 | Sleeved IC 3 Family Sleeved IC 3 SWT (name Not Finalized) Sleeved IC 3 Pocket (name Not Finalized) Sleeved IC 3 Plus (name Not Finalized) Sleeved IC 3 Plus Pocket (name Not Finalized) (N/A) |
Hollister Incorporated | 10/03/2025 | EZD |
| K252820 | PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus) |
Internacional Farmacéutica S.A de C.V |
10/03/2025 | GAM |
| K251426 | Da Vinci SP Surgical System (SP1098) |
Intuitive Surgical, Inc. | 10/03/2025 | NAY |
| K251464 | TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser Unit) |
Jeisys Medical Incorporated |
10/03/2025 | GEX |
| K252178 | MAGENTIQ-COLO (ME-APDS) | Magentiq Eye LTD | 10/03/2025 | QNP |
| K252517 | Manual Wheelchair (SYIV100A008) |
Ningbo Shenyu Medical Equipment Co.,Ltd |
10/03/2025 | IOR |
| K251859 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) |
Olympus Medical Systems Corporation |
10/03/2025 | ODG |
| K243968 | Revolve Surgical System | Revolve Surgical Inc. | 10/03/2025 | GCJ |
| K242946 | HESTIA (L200-A) | Senbitec Co., Ltd | 10/03/2025 | GEX |
| K252806 | Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.) |
Shanghai AnQing Medical Instrument Co., Ltd. |
10/03/2025 | FGB |
| K252129 | AETOS Shoulder System Stemless Humeral Prosthesis |
Smith & Nephew, Inc. | 10/03/2025 | PKC |
| K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 |
Tosoh Bioscience, Inc. | 10/03/2025 | PDJ |
| K243152 | GelPOINT V-Path Transvaginal Access Platform With Retroperitoneal Access Device |
Applied Medical Resources Corp. |
10/02/2025 | HEW |
| K252059 | CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve And Conduit (SGPV00) |
Artivion, Inc. | 10/02/2025 | OHA |
| K250860 | BreatheBand® (Model 1000) | Exemplar Medical, LLC | 10/02/2025 | BYI |
| K251124 | G-Bond Universal | GC America, Inc. | 10/02/2025 | KLE |
| K252440 | EasyTeleMed (2.0.2) | Ingeniars S.r.l. | 10/02/2025 | DRG |
| K252114 | MTS Aztreonam-Avibactam 0.016/4 - 256/4 Μg/ml |
Liofilchem s. r. l. | 10/02/2025 | JWY |
| K251442 | TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) |
Ningbo Tianyi Medical Appliance Co., Ltd. |
10/02/2025 | FJK |
| K252758 | Cannulated Screw And Kirschner (K Wire) System |
OrthoNovis, Inc. | 10/02/2025 | HWC |
| K251215 | Philips IntelliSpace Cardiovascular |
Philips Medical Systems Nederland B.V. |
10/02/2025 | LLZ |
| K251398 | IPL Hair Removal Device (IPL-001, IPL-002) |
Shenzhen Enmind Technology Co., Ltd. |
10/02/2025 | OHT |
| K252769 | Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116) |
Shenzhen Finicare Co., Ltd. |
10/02/2025 | DXN |
| K250551 | 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) |
Shenzhen Sophway Technology Co., Ltd. |
10/02/2025 | GCJ |
| K250523 | Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5) |
Simergent, LLC | 10/02/2025 | FKX |
| K250766 | LungQ 4 | Thirona BV | 10/02/2025 | JAK |
| K251501 | Visby Medical Men's Sexual Health Test |
Visby Medical, Inc. | 10/01/2025 | QEP |
| K252447 | Picosecond Laser Device (BMPS4) |
Hebei Newangie Technology Co., Ltd. |
10/01/2025 | GEX |
| K252096 | Light Therapy Decollete Mask (1019135) |
Merchsource LLC | 10/01/2025 | OHS |
| K251899 | E Blator | New Deantronics Taiwan Ltd. |
10/01/2025 | GEI |
| K250767 | Newclip Patient-matched Instrumentation Non Sterile PSI |
NewClip Technics | 10/01/2025 | PBF |
| K250083 | PRO-DOSE System | Nu-Rise, SA | 10/01/2025 | NZT |
| K252804 | Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG;UI20 BK, UI20 BL, UI20 BR, UI20 BS, UI20 DB, UI20 GP, UI20 GR, UI20 MP, UI20 PN, UI20 PW, UI20 RE, UI20 WH; UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB,UI06 PR, UI06 OG,UI06RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG; UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU; UI04 MK, UI04 BN, UI04 BU, UI04 CB, UI04 GY, UI04 LG, UI04 DG, UI04 PL, |
Shenzhen Ulike Smart Electronics Co., Ltd. |
10/01/2025 | OHT |
| K251825 | Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG) |
Shenzhen Ulike Smart Electronics Co.,Ltd. |
10/01/2025 | OHS |
| K251767 | Vena MicroAngioscope™ System | Vena Medical Holdings Corp |
10/01/2025 | LYK |
| K250026 | Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/F H3000/FH1000) |
Wuxi Hisky Medical Technologies Co., Ltd. |
10/01/2025 | IYN |
| K252072 | Francisella Tularensis Real-time PCR Assay |
Centers for Disease Control and Prevention |
09/30/2025 | SGA |
| K250050 | Midiagnostics HSV-1&2 CSF Test | miDiagnostics nv | 09/30/2025 | PGH |
| K251690 | Arthrex SpeedFLEX™ Implant | Arthrex Inc. | 09/30/2025 | OWY |
| K250331 | Astrasono A3Pro Bladder Scanner (A3Pro) |
Astrasono Technology Co., Ltd |
09/30/2025 | IYO |
| K251197 | Dexter L6 System | Distalmotion, SA | 09/30/2025 | SDD |
| K252722 | Biopsy Forceps | FEHLING Instruments GmbH | 09/30/2025 | DWZ |
| K251799 | Mobility Scooter (BBR-Q40-01); Mobility Scooter (BBR-Q40-02); Mobility Scooter (BBR-Q40-03); Mobility Scooter (BBR-Q40-04); Mobility Scooter (BBR-Q40-05); Mobility Scooter (BBR-Q40-06) |
Jiangsu Bangbang Intelligent Technology Co., Ltd. |
09/30/2025 | INI |
| K252106 | External Fixation Mini Rail System |
Paragon 28, Inc. | 09/30/2025 | KTT |
| K251669 | IBP Transducer Adapter Cable, Argon/BD/Ohmeda, 2m; IBP Transducer Adapter Cable, Draeger 10-pin, 2m; IBP Transducer Adapter Cable, Draeger 7-pin, 2m; IBP Transd. Adapter Cbl, Abbott/Medex, Smiths/TranStar 2m; IBP Transducer Adapter Cable, Baxter/Edwards, 0.3m; IBP Transducer Adapter Cable, Baxter/Edwards, 2m; IBP Transducer Adapter Cable, Argon/BD/Ohmeda, 0.3m; IBP Transducer Adapter Cable, Draeger 10-pin, 0.3m; IBP Transducer Adapter Cable, Draeger 7-pin, 0.3m; IBP Transducer Adapter |
Shanghai Draeger Medical Instrument Co., Ltd. |
09/30/2025 | DSA |
| K243270 | TigerConnect Alarm Management | TigerConnect | 09/30/2025 | MSX |
| K252085 | Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) |
Wright Medical Technology, Inc. (Stryker Corporation) |
09/30/2025 | MQV |
| K252770 | Ilet ACE Pump | Beta Bionics, Inc. | 09/29/2025 | QFG |
| K250023 | SMART PCFD | Disior Ltd | 09/29/2025 | QIH |
| K253236 | G-BLOCK | Graphenano Dental S.L. | 09/29/2025 | EBF |
| K250123 | Master-Pin X (MP Pin With Thread) (36BMP000030 / MP30) |
Hager & Meisinger GmbH | 09/29/2025 | DZL |
| K251334 | NEW DOUBLO 2.0 | Hironic Co., Ltd. | 09/29/2025 | GEI |
| K243833 | Portable Oxygen Concentrator (JAY-1000P) |
LONGFIAN SCITECH CO., LTD |
09/29/2025 | CAW |
| K243983 | Paltop Dental Implant System | Paltop Advanced Dental Solutions, Ltd |
09/29/2025 | DZE |
| K252594 | UltraGuideCTR® Image Guided Soft Tissue Release System |
Sonex Health | 09/29/2025 | HRX |
| K252441 | Primero Safe Access System | South53, LLC. | 09/29/2025 | DYB |
| K252054 | SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. | 09/29/2025 | SBF |
| K252051 | Allay Nerve Cap (TL5515-1); Allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) |
Tulavi Therapeutics, Inc. |
09/29/2025 | SBG |
| K251104 | SureTome™ SW Sphincterotome With DomeTip |
Wilson-Cook Medical | 09/29/2025 | KNS |
| K250659 | LoFric Origo | Wellspect AB | 09/26/2025 | EZD |
| K251208 | Tuned Self-Fitting Mobile App | Tuned Ltd. | 09/26/2025 | SCR |
| K252221 | Inset Reverse Total Shoulder System |
Shoulder Innovations, Inc. |
09/26/2025 | |
| K251262 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda |
09/26/2025 | DZE |
| K250318 | Planmed XFI | Planmed Oy | 09/26/2025 | SFV |
| K251986 | AUXILIARY WATER TUBE MAJ-855 | Olympus Medical Systems Corporation |
09/26/2025 | OCX |
| K251919 | Thulium Laser System (Deluxlase) |
Nanjing Bestview Laser S&T Co., Ltd. |
09/26/2025 | GEX |
| K250093 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) |
Linshom Medical, Inc. | 09/26/2025 | BZQ |
| K252105 | Ligence Heart | Ligence, UAB | 09/26/2025 | QIH |
| K252435 | Magnetic Surgical System | Levita Magnetics International Corp |
09/26/2025 | PNL |
| K251204 | FUJIFILM Stiffening Wire Device (SW-2000) |
FUJIFILM Healthcare Americas Corporation |
09/26/2025 | FDA |
| K251275 | VitalStream ART Connect; VitalStream-Hemo |
Caretaker Medical | 09/26/2025 | DXG |
| K251645 | Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 With Calculated DAP |
Canon Medical Systems Corporation |
09/26/2025 | JAK |
| K252921 | Radial Jaw 4 Pulmonary Biopsy Forceps |
Boston Scientific Corporation |
09/26/2025 | BWH |
| K252700 | Optima Coil System (Optima Packing Coil System) |
Balt USA, LLC | 09/26/2025 | HCG |
| K252102 | Alinity M HCV | Abbott Molecular Inc. | 09/25/2025 | MZP |
| K251868 | Panther Fusion GI Bacterial Assay |
Hologic | 09/25/2025 | PCH |
| K251993 | Panther Fusion GI Expanded Bacterial Assay |
Hologic Inc. | 09/25/2025 | PCH |
| K252062 | The Sensititre 18-24 Hour MIC Or Breakpoint Susceptibility System With Colistin In The Dilution Range Of 0.12-16 Ug/ml |
Thermofisher Scientific | 09/25/2025 | JWY |
| K244009 | Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens For Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable) |
Yung Sheng Optical Co., Ltd. |
09/25/2025 | LPL |
| K252063 | Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN) |
Wuhan Dimed Laser Technology Co., Ltd. |
09/25/2025 | GEX |
| K252725 | Stem Extension Line (U2 Total Knee System—PSA Type) |
United Orthopedic Corporation |
09/25/2025 | JWH |
| K251971 | RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer |
Stryker Instruments | 09/25/2025 | OLO |
| K252371 | Umr 680 | Shanghai United Imaging Healthcare Co., Ltd. |
09/25/2025 | LNH |
| K250837 | Pulse Oximeter | Shanghai Berry Electronic Tech Co., Ltd |
09/25/2025 | DQA |
| K251527 | Brain WMH | Quantib BV | 09/25/2025 | QIH |
| K251997 | Single-Use Biopsy Valve (MAJ-1555) |
Olympus Medical Systems Corporation |
09/25/2025 | OCX |
| K251789 | EMBOTRAP III Revascularization Device |
Neuravi Limited | 09/25/2025 | NRY |
| K251812 | Steripath® Flow™ Blood Collection System |
Magnolia Medical Technologies |
09/25/2025 | JKA |
| K251148 | JDEvolution Plus L And JDEvolution Plus LE |
JDentalCare Srl | 09/25/2025 | |
| K250076 | Endeavor™ Stand-Alone Cervical IBF System |
Innovasis | 09/25/2025 | OVE |
| K251465 | Root Canal Repair Materials (nRoot BP) |
Enpuno Biotechnology Co., Ltd |
09/25/2025 | KIF |
| K243785 | Shiley™ Oral/Nasal Tracheal Tube With TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced With Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced |
Covidien LLC | 09/25/2025 | BTR |
| K251512 | Hi Bebe Super (BT-150B) | Bistos Co., Ltd. | 09/25/2025 | HGX |
| K251791 | Auxano® Wedge Fixation System | Auxano Medical LLC | 09/25/2025 | PLF |
| K252013 | EnSite™ X EP System | Abbott Medical | 09/25/2025 | DQK |
| K250792 | T:slim X2 Insulin Pump With Interoperable Technology |
Tandem Diabetes Care, Inc. |
09/24/2025 | QFG |
| K252227 | Pounce(TM) Sheath | Surmodics, Inc. | 09/24/2025 | DYB |
| K252680 | Celerity™ 20 HP Biological Indicator |
STERIS Corporation | 09/24/2025 | FRC |
| K250045 | Uws-angio Pro | Shanghai United Imaging Healthcare Co., Ltd. |
09/24/2025 | LLZ |
| K252183 | Resitu Slider 09 (RESL09) | Resitu Medical AB | 09/24/2025 | KNW |
| K251734 | ProVee Video Processing Unit (PV-003) |
ProVerum Limited | 09/24/2025 | FET |
| K243910 | Retraxil | Kulzer, LLC | 09/24/2025 | MVL |
| K252689 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) |
Imaxeon Pty Ltd | 09/24/2025 | IZQ |
| K244029 | ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) |
EndoRobotics Co., Ltd. | 09/24/2025 | FDF |
| K251206 | Digital X-Ray DentiMax Pro Imaging System |
DENTIMAX, INC | 09/24/2025 | MUH |
| K252703 | LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard With Pressure Monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse With Pressure Monitoring (M0067940500) |
Boston Scientific Corporation |
09/24/2025 | FGB |
| K250071 | Alma FemiLift Pixel CO2 Laser System, Delivery Devices And Accessories |
Alma Lasers, Inc | 09/24/2025 | GEX |
| K252682 | LenSx Laser System (8065000944) |
Alcon Laboratories, Inc. | 09/24/2025 | OOE |
| K251140 | Zenflow Spring Scope | Zenflow, Inc. | 09/23/2025 | FAJ |
| K252043 | Bipolar Applicator CelonProBreath (WB990310); Bipolar Applicator CelonProSleep Plus (WB990311); Bipolar Applicator CelonProBreath (WB990210); Bipolar Applicator CelonProSleep Plus (WB990211) |
Olympus Winter & Ibe GmbH |
09/23/2025 | GEI |
| K252644 | PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture |
M/s. Meril Endo Surgery Private Limited |
09/23/2025 | NEW |
| K251973 | Luminance Red Cold Sore Device (TN1927G) |
Luminance Medical Ventures, Inc. |
09/23/2025 | OKJ |
| K251987 | Rapid Aortic Measurements | iSchemaView, Inc. | 09/23/2025 | QIH |
| K252045 | Ion Endoluminal System (IF1000) |
Intuitive Surgical, Inc. | 09/23/2025 | EOQ |
| K251894 | Himaging Bronchscope System | Himaging Technology (Shanghai) Co., Ltd. |
09/23/2025 | EOQ |
| K253053 | Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21- B1) |
Hangzhou SHINING3D Dental Technology Co., Ltd. |
09/23/2025 | EBF |
| K251982 | Edwards MC3 Tricuspid Annuloplasty Ring (4900) |
Edwards Lifesciences LLC | 09/23/2025 | KRH |
| K250209 | Polyvinyl Alcohol Embolic Microspheres |
Canyon Medical Inc. | 09/23/2025 | KRD |
| K251483 | SwiftSight-Brain | AIRS Medical Inc. | 09/23/2025 | QIH |
| K250205 | Babio® Virus Transport Kit (Non-inactivating) |
Jinan Babio Biotechnology Co., Ltd. |
09/22/2025 | JSM |
| K251743 | SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System |
Surgical Principals, Inc. |
09/22/2025 | GCJ |
| K250388 | ENDOFLATOR + | Karl Storz SE & Co. KG | 09/22/2025 | HIF |
| K243645 | IC-Flow™ Imaging System 2.0 | Diagnostic Green GMBH | 09/22/2025 | IZI |
| K252315 | Santreva™-ATK Endovascular Revasculariztion Catheter |
AngioSafe, Inc. | 09/22/2025 | PDU |
| K250128 | Single Use Suction-Evacuation Ureteral Access Sheath |
ANHUI HAPPINESS WORKSHOP MEDICAL INSTRUMENTS CO., LTD |
09/19/2025 | FED |
| K241868 | Xr IVD | Tempus AI, Inc. | 09/19/2025 | PZM |
| K250408 | Alegria Flash ENA Screen | ZEUS Scientific | 09/19/2025 | LLL |
| K251002 | Videa Dental AI | VideaHealth Inc. | 09/19/2025 | MYN |
| K252285 | Well-Root PT | Vericom Co., Ltd. | 09/19/2025 | KIF |
| K252613 | Unscented Menstrual Three-piece Applicator Tampon |
Unibeauty (Hubei) Technology Co.,Ltd. |
09/19/2025 | HEB |
| K244035 | Portable Mesh Nebulizer (JM821) |
Shenzhen Jermei Medical Device Technology Co., Ltd. |
09/19/2025 | CAF |
| K251167 | Udr Aurora CX | Shanghai United Imaging Healthcare Co., Ltd. |
09/19/2025 | KPR |
| K243990 | BondEase 2 Topical Skin Adhesive |
OptMed, Inc. | 09/19/2025 | MPN |
| K251867 | EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) |
Olympus Medical Systems Corp. |
09/19/2025 | FDT |
| K252657 | Impact PEEK Union Nail System | Nvision Biomedical Technologies INC. |
09/19/2025 | HTY |
| K252662 | UniBur | Nakanishi Inc. | 09/19/2025 | HBE |
| K251689 | VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) |
NAKANISHI INC. | 09/19/2025 | ELC |
| K243920 | Purema H Hemoconcentrator - Pediatric |
MEDICA USA Inc. | 09/19/2025 | KDI |
| K250450 | Coated Hip Implants | Medacta International S.A. |
09/19/2025 | LZO |
| K251100 | IPGTFL-02 | IPG Medical Corporation | 09/19/2025 | GEX |
| K242859 | VEGA | Ibramed Equipamentos Médicos |
09/19/2025 | GEX |
| K250777 | Sonicaid Team3 | Huntleigh Healthcare Ltd. |
09/19/2025 | HGM |
| K250953 | EQUIA LC ONE | GC America Inc. | 09/19/2025 | EMA |
| K252647 | Tapestry Biointegrative Implant |
Embody, Inc. | 09/19/2025 | OWY |
| K250649 | Bunkerhill ECG-EF | BunkerHill Health | 09/19/2025 | QYE |
| K252428 | Electric Wheelchair (Model P2) | Superpi Robot Co., Ltd. | 09/18/2025 | ITI |
| K251649 | Sunny Plus (Sunny) | ShenB Co., Ltd | 09/18/2025 | NFO |
| K251597 | InnerView System | Perimetrics, Inc. | 09/18/2025 | EKX |
| K250883 | ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) |
Olympus Medical Systems Corporation |
09/18/2025 | ITX |
| K251905 | Normatec Elite Hip | NormaTec Industries, LP | 09/18/2025 | IRP |
| K251479 | Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF)) |
Mobarn Medical Devices, LLC. |
09/18/2025 | MAX |
| K251377 | Magic InBra | Medela AG | 09/18/2025 | HGX |
| K250369 | Axial3D Insight | Axial Medical Printing Limited |
09/18/2025 | QIH |
| K251902 | Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask With Shield (Vitaform-FS) |
Vitacore Industries Inc. | 09/17/2025 | FXX |
| K243752 | Double Tube Herbst Appliance | the tmj clinic PC | 09/17/2025 | LRK |
| K251623 | Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061 ) |
Shenzhen Yicai Health Technology Co. Ltd |
09/17/2025 | IRP |
| K252615 | Ruthless Spine RJB | Ruthless, LLC dba Ruthless Spine |
09/17/2025 | QWL |
| K251446 | PlasmaFlow X Compression Sleeve Device (XPF0001) |
ManaMed, LLC | 09/17/2025 | JOW |
| K252035 | DENTURE SOFT EX (Pink Set); DENTURE SOFT EX (White Set); DENTURE SOFT EX (Pink Powder); DENTURE SPFT EX (White Powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial Kit Pink); DENTURE SOFT EX (Trial Kit White) |
Kamemizu Chemical Industry Co., Ltd |
09/17/2025 | EBI |
| K244006 | FG Bone Graft M | Full Golden Biotech Co., Ltd. |
09/17/2025 | LYC |
| K251386 | ECHELON Synergy | Fujifilm Corporation | 09/17/2025 | LNH |
| K251688 | Carpentier-Edwards Physio Annuloplasty Ring (4450) |
Edwards Lifesciences LLC | 09/17/2025 | KRH |
| K251221 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) |
Abbott | 09/17/2025 | MXD |
| K251095 | Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses |
Pegavision Corporation | 09/17/2025 | LPL |
| K251676 | Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) |
Microtek Medical LLC | 09/16/2025 | LHI |
| K252540 | ACCUJECT Injector Set 2.1-1P (LP604590) |
Medicel AG | 09/16/2025 | MSS |
| K251650 | Insight Enhanced™ DRF (EN-1002-01) |
Imaging Engineering LLC | 09/16/2025 | JAA |
| K242287 | SFIT Abutment | Cowellmedi Co., Ltd. | 09/16/2025 | NHA |
| K250609 | Sober Self-Test | Sober IP LLC | 09/15/2025 | DIC |
| K252128 | Zener® (model ZEN-001-B1) | UVX Inc. | 09/15/2025 | FRA |
| K251780 | Igps Navigation Instruments | SI-BONE Inc. | 09/15/2025 | OLO |
| K252598 | Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) |
Shanghai AnQing Medical Instrument Co., Ltd. |
09/15/2025 | FAJ |
| K251869 | Disposable Prophy Angle (3399-60, 3399-090, 3399-105) |
Premium Plus (Dongguan) Limited |
09/15/2025 | EGS |
| K251914 | IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal Device (MLY-M013); IPL Hair Removal Device (MLY-M015); IPL Hair Removal Device (MLY-T001); IPL Hair Removal Device (MLY-T002) |
Miley Technology (Hebei) Co., Ltd. |
09/15/2025 | OHT |
| K252443 | SpaceFix Shoulder Spacer | G21 S.R.L | 09/15/2025 | MBB |
| K250237 | InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. |
09/15/2025 | QIH |
| K250689 | CloudTMS Edge | TeleEMG, LLC | 09/14/2025 | OBP |
| K251449 | BrainsWay Deep TMS System | BrainsWay Ltd. | 09/13/2025 | OBP |
