IFU is not found for this 510(k).
| 510(k) Number | Device Name | Applicant | Decision Date | Procode |
|---|---|---|---|---|
| K252842 | SafeOp 3: Neural Informatix System |
Alphatec Spine, Inc. | 01/11/2026 | GWF |
| K252589 | Corvair Monza | AliveCor, Inc. | 01/09/2026 | MHX |
| K252906 | ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) |
Ethicon Endo-Surgery, LLC |
01/09/2026 | OXC |
| K254003 | JARVIS Metaphyseal Stem | FH Industrie | 01/09/2026 | PHX |
| K251139 | KabiHelp® Uno; KabiHelp® Advance Plus |
Fresenius Kabi AG | 01/09/2026 | KPE |
| K253550 | Self-Forming Magnet (Flexagon Plus OTOLoc) |
Gi Windows, Inc. | 01/09/2026 | SAH |
| K253957 | HemosIL Silica Clotting Time | Instrumentation Laboratory (IL) Co. |
01/09/2026 | GFO |
| K252339 | Iotasoft® Insertion System | Iotamotion, Inc. | 01/09/2026 | QQH |
| K253973 | Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, And SP Series |
Liaoning Upcera Co., Ltd. |
01/09/2026 | EIH |
| K252847 | NextAR Hip Platform | Medacta International S.A. |
01/09/2026 | OLO |
| K253142 | Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8 D,RN3D,MJ4D,RN1D,RN2D) |
Ningbo Ranor Medical Technology Co., Ltd. |
01/09/2026 | DXN |
| K252206 | Nova Allegro UACR Assay, Nova Allegro Analyzer |
Nova Biomedical Corporation |
01/09/2026 | CGX |
| K252674 | Solo Pace Fusion System (SOLOFUSE1) |
Solo Pace, Inc. | 01/09/2026 | DQX |
| K253075 | Mobility Scooter (Air Classic); Mobility Scooter (Air Traveller); Mobility Scooter (Air Traveller2.0) |
Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. |
01/09/2026 | INI |
| K251157 | Core Metabolic | Truvian Health | 01/09/2026 | CIX |
| K253964 | Disposable Neonatal NIBP Cuff (U1681S-C51N) |
Unimed Medical Supplies, Inc. |
01/09/2026 | DXQ |
| K253639 | View | Ge Healthcare | 01/08/2026 | LLZ |
| K253370 | LOGIQ Totus | Ge Medical Systems Ultrasound and Primary Care Diagnostics |
01/08/2026 | IYN |
| K252794 | Vision-MR™ Diagnostic Catheter |
Imricor Medical Systems, Inc. |
01/08/2026 | DRF |
| K252711 | Advantage-C™ Ti3D Cervical Interbody Fusion Device |
Intelivation Technologies |
01/08/2026 | ODP |
| K252585 | ZENEX Implant System_R-System | Izenimplant Co., Ltd. | 01/08/2026 | DZE |
| K252759 | Revyve® Antimicrobial Skin And Wound Cleanser |
Kane Biotech, Inc. | 01/08/2026 | FRO |
| K253512 | MiniMed Go App | Medtronic Minimed | 01/08/2026 | NDC |
| K251160 | Sterile Temperature Probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS) |
Shenzhen Med-Link Electronics Tech Co., Ltd. |
01/08/2026 | FLL |
| K253784 | 3DICOM MD Cloud | Singular Health Pty, Ltd. |
01/08/2026 | LLZ |
| K253266 | Titanium Interbody System | Spine Innovation, LLC | 01/08/2026 | MAX |
| K252788 | Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) |
Tornier, Inc. | 01/08/2026 | PHX |
| K252669 | Fetal Doppler U8-25, U9-25 | Zhongshan Xiaolan Town Senlan Electronic Factory |
01/08/2026 | KNG |
| K253923 | PuraStat | 3-D Matrix Europe SAS | 01/07/2026 | PHN |
| K253924 | PuraStat | 3-D Matrix Europe SAS | 01/07/2026 | QAU |
| K252970 | BriefCase-Triage: CARE Multi-triage CT Body |
Aidoc Medical , Ltd. | 01/07/2026 | QAS |
| K252507 | SmileInspector | Amv Consulting, LLC | 01/07/2026 | PNN |
| K251207 | Sangria™ Thrombectomy System | Avantec Vascular Corporation |
01/07/2026 | QEW |
| K251454 | Clear Aligner (SCF-3348) | Beame Medical Technology (Shenzhen) Limited |
01/07/2026 | NXC |
| K253009 | DS Core Detect | Dentsply Sirona, Inc. | 01/07/2026 | MYN |
| K253366 | LOGIQ Fortis | Ge Medical Systems Ultrasound and Primary Care Diagnostics |
01/07/2026 | IYN |
| K250305 | Reprocessed Agilis NxT Steerable Introducer |
Innovative Health | 01/07/2026 | PNE |
| K252727 | Neodent InLab Validated Workflow |
JJGC Indústria e Comércio de Materiais Dentários S.A. |
01/07/2026 | NHA |
| K252890 | ZenSeal Pro | Kerr Corporation | 01/07/2026 | KIF |
| K253308 | Materialise Personalized Guides And Models For Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models |
Materialise N.V | 01/07/2026 | PPT |
| K253941 | CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) |
Medtronic Sofamor Danek USA, Inc. |
01/07/2026 | NKB |
| K253939 | DeltaWave Nasal Pillow System | RemSleep Holdings, Inc. | 01/07/2026 | BZD |
| K253990 | KHEIRON® Spinal Fixation System, Including Patient Specific K-ROD |
S.M.A.I.O | 01/07/2026 | NKB |
| K253109 | Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) |
Shenzhen Best Electronics Co., Ltd. |
01/07/2026 | DQA |
| K253158 | VyBrate™ VBR System | Vy Spine, LLC | 01/07/2026 | MQP |
| K253618 | QuadLock™ Fixation System | Abanza Tecnomed S.L | 01/06/2026 | MBI |
| K252894 | Aprevo® Cervical Interbody System |
Carlsmed, Inc. | 01/06/2026 | ODP |
| K253178 | TRILEAP Plating System | Crossroads Extremity Systems |
01/06/2026 | HRS |
| K250341 | Sensilift Pro (ST300XXYYZZZ) | El Global Trade, Ltd. | 01/06/2026 | PAY |
| K252886 | Pen Needle | Hh Global Technology, Inc. |
01/06/2026 | FMI |
| K251165 | Saans (F4-01-00-000-000) | Innaccel Technologies Private Limited |
01/06/2026 | SGR |
| K253793 | Materialise TKA Guide System | Materialise N.V | 01/06/2026 | JWH |
| K252749 | Medconn 8K Glycated Hemoglobin Test System |
Shanghai Medconn Medical Technology Co., Ltd. |
01/06/2026 | PDJ |
| K251097 | V-DAC Catheter | Vesalio, Inc. | 01/06/2026 | QJP |
| K251757 | Puracyn® Plus Antimicrobial Irrigation Solution |
Innovacyn, Inc. | 01/05/2026 | FRO |
| K251668 | SurfRider 13 Microcatheter | Kaneka Americas Holding, Inc. |
01/05/2026 | QJP |
| K253008 | Mailink | Maihub Corp. | 01/05/2026 | LLZ |
| K252650 | Disposable Medical Face Mask | Makrite Industries, Inc. | 01/05/2026 | FXX |
| K252988 | ChartCheck (RADCH V1.6) | Radformation, Inc. | 01/05/2026 | IYE |
| K252018 | HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
01/05/2026 | IYN |
| K251630 | Atellica IM Total PSA II (tPSAII) |
Siemens Healthcare Diagnostics, Inc. |
01/05/2026 | LTJ |
| K253854 | MONTAGE XT Cranial Cement | Orthocon, Inc. | 01/02/2026 | GXP |
| K251178 | Ready To Use Nelaton Catheter | Jamjoom Fullcare Corporation |
01/02/2026 | EZD |
| K252817 | Mobility Scooter (BC-MS310) | Ningbo Baichen Medical Devices Co., Ltd. |
01/02/2026 | INI |
| K253867 | FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit |
ZuriMED Technologies AG | 01/02/2026 | |
| K243627 | Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) |
Arc Trauma, LLC | 12/31/2025 | DXC |
| K252951 | Genesis Sleep | Neurofield, Inc. | 12/31/2025 | QJQ |
| K253305 | TENS AND EMS (TENS And Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) |
Shenzhen Jiantuo Electronics Co., Ltd. |
12/31/2025 | NUH |
| K253888 | MOLLI 2 System | Stryker Endoscopy | 12/31/2025 | NEU |
| K252901 | Tyber Medical Trauma Screw | Tyber Medical, LLC | 12/31/2025 | |
| K253895 | Arthrex SwiveLock Suture Anchor, 3.5 X 10 Mm |
Arthrex, Inc. | 12/30/2025 | MBI |
| K250168 | Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer |
Lucas Lifecare | 12/30/2025 | FLE |
| K253844 | AnyScan 3.0 NM Scanner Family | Mediso Medical Imaging Systems, Ltd. |
12/30/2025 | KPS |
| K253532 | TruSPECT Processing Station | Spectrum Dynamics Medical, Ltd. |
12/30/2025 | QIH |
| K251091 | Lipids | Truvian Health | 12/30/2025 | CHH |
| K242492 | Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN) |
Techno-Path Manufacturing , Ltd. |
12/30/2025 | QCH |
| K253343 | Celebrace Software | Celebrace | 12/29/2025 | PNN |
| K251025 | Mon-a-Therm™ Esophageal Stethoscope With Temperature Sensor 400TM (90041, 90042, 90043, 90049) |
Covidien, LLC | 12/29/2025 | BZT |
| K251313 | Shiley™ Adult Flexible Tracheostomy Tube XLT With TaperGuard™ Cuff, Distal With Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT With TaperGuard™ Cuff, Proximal With Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal With Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal With Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLT |
Covidien, LLC | 12/29/2025 | JOH |
| K251534 | Oxygen Concentrator (J10A) | Foshan Kycare Medical Equipment Co., Ltd. |
12/29/2025 | CAW |
| K253881 | Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM) |
Shenzhen Fansizhe Science And Technology Co., Ltd. |
12/29/2025 | OHT |
| K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M Stent |
Taewoong Medical Co., Ltd. |
12/29/2025 | FGE |
| K253325 | ZipToe™ Hammertoe Fusion System |
Toetal Solutions | 12/29/2025 | HTY |
| K253279 | Feather/numiere 05 06 07 (05) | Heat IN A Click, LLC | 12/24/2025 | OHS |
| K253349 | Hair Regrowth Cap (Model: T-119-HRC) |
Light Tree Ventures Europe B.V. |
12/24/2025 | OAP |
| K253400 | LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) |
Shenzhen Saidi Light Therapy Technology Co., Ltd. |
12/24/2025 | OHS |
| K253342 | PICO-K | Speclipse, Inc. | 12/24/2025 | GEX |
| K252187 | Aura Glide (FC40) | Aura Medical, LLC | 12/23/2025 | NFO |
| K251683 | Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens With UV Blocking For Presbyopia (EDOF) |
Bruno Vision Care, LLC | 12/23/2025 | LPL |
| K252633 | UNITY DX (UDX) | Cylite Pty. , Ltd. | 12/23/2025 | OBO |
| K251978 | LIAISON NES FLU A/B, RSV & COVID-19 |
Diasorin Molecular, LLC | 12/23/2025 | QOF |
| K253135 | LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,H LG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.) |
Dongguan Yijiaming Technology Co., Ltd. |
12/23/2025 | OHS |
| K251958 | VEINOPLUS Back | Dynapulse Medical | 12/23/2025 | |
| K251268 | Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, And Nano L12 EXP) |
Edan Instruments, Inc. | 12/23/2025 | |
| K252379 | AIR Recon DL | Ge Medical Systems, LLC | 12/23/2025 | LNH |
| K252835 | Electric Scooter (S202572J, S2060, M2089, S2050) |
Guangdong Prestige Technology Co., Ltd. |
12/23/2025 | INI |
| K251800 | Healgen® URS Test Strips | Healgen Scientific, LLC | 12/23/2025 | JMT |
| K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card |
Healgen Scientific, LLC | 12/23/2025 | NGL |
| K253740 | TENS&EMS (HZ9151B, HZ9151C, HZ9151D) |
Hong Qiangxing (Shenzhen) Electronics Limited |
12/23/2025 | NUH |
| K252493 | NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp Spp.); Capture Reagent F207, Clam (Mercenaria Mercenaria); Capture Reagent F256, Walnut (Juglans Spp.) ; Capture Reagent I006, German Cockroach (Blatella Germanica) |
Hycor Biomedical | 12/23/2025 | DHB |
| K253072 | Paruu Wearable Breast Pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D) |
Linhejiacheng (Shenzhen) E-Commerce Co., Ltd. |
12/23/2025 | HGX |
| K253341 | Custom Abutments AS | Medentika GmbH | 12/23/2025 | NHA |
| K253217 | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) |
Medimaging Integrated Solution, Inc (Miis) |
12/23/2025 | HRX |
| K254163 | VarioSurg 4 | Nakanishi, Inc. | 12/23/2025 | DZI |
| K253312 | OrangeCAD Med Abutments | Orangecad Med GmbH | 12/23/2025 | NHA |
| K253675 | OsteoRemedies Hip Spacer System |
Osteoremedies, LLC | 12/23/2025 | KWL |
| K250476 | NizPlant Dental Implant System | Paragon Implant Mfg., LLC |
12/23/2025 | DZE |
| K252145 | GEN5™ And GEN5+™ 3.3mmD Dental Implants |
Paragon Implant Mfg., LLC |
12/23/2025 | DZE |
| K253754 | Philips Lumea IPL | Philips Consumer Lifestyle B.V. |
12/23/2025 | OHT |
| K251991 | SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) |
Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. |
12/23/2025 | JOJ |
| K252146 | Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) |
Shenzhen Siken 3D Technology Development Co., Ltd. |
12/23/2025 | NFO |
| K253239 | Active-V Total Knee System; World Total Knee System |
Signature Orthopaedics Pty, Ltd. |
12/23/2025 | MBH |
| K253122 | Sim&Size | Sim&Cure | 12/23/2025 | PZO |
| K253091 | ART-Plan+ (v3.1.0) | Therapanacea Sas | 12/23/2025 | MUJ |
| K253281 | UpDoc | Updoc, Inc. | 12/23/2025 | NDC |
| K252361 | AccurECG Analysis System (v2.0) |
Accurkardia, Inc. | 12/22/2025 | DPS |
| K253727 | Syndesmosis TightRope PRO | Arthrex, Inc. | 12/22/2025 | HTN |
| K251019 | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G And BT-PDS-SERIES-G |
Bioteque Corporation | 12/22/2025 | FGE |
| K250959 | BioticsAI | Bioticsai, Inc. | 12/22/2025 | IYN |
| K252611 | Aprevo® Cervical Plating System |
Carlsmed, Inc. | 12/22/2025 | KWQ |
| K251605 | DIMPLO Implant System | Dimplo , Ltd. | 12/22/2025 | DZE |
| K251105 | Tetra (TM-20); Tetra (TM-50) | Emed Technologies Corporation |
12/22/2025 | PKP |
| K252981 | EmbraceMini | Empatica S.R.L. | 12/22/2025 | LEL |
| K252743 | STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device |
Ethicon, Inc. | 12/22/2025 | GAM |
| K253876 | HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) |
Globus Medical, Inc. | 12/22/2025 | OVE |
| K253769 | Instylla Delivery Kit | Instylla, Inc. | 12/22/2025 | FMF |
| K253664 | SKOUT System | Iterative Health | 12/22/2025 | QNP |
| K243342 | KP Protective Face Mask | Kp Trading Co., Ltd. | 12/22/2025 | FXX |
| K252673 | LacertaMatrix | Lacerta Life Science | 12/22/2025 | KGN |
| K252068 | MC2 Portable X-ray System | Oxos Medical | 12/22/2025 | OWB |
| K252856 | PeekMed Web | Peek Health, S.A. | 12/22/2025 | QIH |
| K252557 | Lumify Diagnostic Ultrasound System |
Philips Ultrasound, LLC | 12/22/2025 | IYN |
| K250756 | Pression Wave PRO External Counter-Pulsation System |
Pression, Inc. | 12/22/2025 | DRN |
| K251764 | Oxygen Concentrator-P2-O5E | Qingdao Kingon Medical Science and Technology Co., Ltd. |
12/22/2025 | CAW |
| K252109 | RayStation (2024A SP3) | RaySearch Laboratories AB (PUBL) |
12/22/2025 | MUJ |
| K252616 | Portable Oxygen Concentrator (JLO-190P) |
Shenzhen Homed Medical Device Co., Ltd. |
12/22/2025 | CAW |
| K251783 | Inspire HCR And HCR DUAL Cardiotomy Reservoirs |
Sorin Group Italia S.R.L. |
12/22/2025 | DTN |
| K253339 | Theracor | Stimlabs, LLC | 12/22/2025 | KGN |
| K253781 | InnoClip Clip Applier | Taiwan Surgical Corporation |
12/22/2025 | FZP |
| K253903 | InnoClip Disposable Clip Applier |
Taiwan Surgical Corporation |
12/22/2025 | FZP |
| K253661 | TMINI Miniature Robotic System | THINK Surgical, Inc. | 12/22/2025 | OLO |
| K253222 | Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) |
Zhejiang Gongdong Medical Technology Co., Ltd. |
12/22/2025 | MMK |
| K251159 | Power Wheelchair | Zhenjiang Assure Medical Equipment Co., Ltd. |
12/22/2025 | ITI |
| K252480 | CE Deliver (DLV) | CapsoVision, Inc. | 12/19/2025 | NEZ |
| K251469 | Endura™ Ureteral Stent And Stent Set |
Cathegenix (Xiamen) Co., Ltd. |
12/19/2025 | FAD |
| K252284 | Emurmur Heart AI | Csd Labs | 12/19/2025 | DQD |
| K251152 | DBLG2 | Diabeloop | 12/19/2025 | QJI |
| K253358 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay |
Diazyme Laboratories, Inc. |
12/19/2025 | DFH |
| K252974 | EMPOWR Knee | Encore Medical, L.P. | 12/19/2025 | JWH |
| K253479 | Optiflow Switch+ Filtered Nasal Interface With CO2 Sampling (AA042J) |
Fisher &Paykel Healthcare , Ltd. |
12/19/2025 | BTT |
| K251050 | Pectus Versa System | Gm Dos Reis Industria E Comercio |
12/19/2025 | HRS |
| K252342 | Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) |
Guangdong Youmeng Electrical Technology Co., Ltd. |
12/19/2025 | HGX |
| K252754 | Wearable Electric Breast Pump (YM-8803) |
Guangdong Youmeng Electrical Technology Co., Ltd. |
12/19/2025 | HGX |
| K252029 | AI-CVD | HeartLung Corporation | 12/19/2025 | QIH |
| K254063 | Icem Universal Plus | Kulzer, LLC | 12/19/2025 | EMA |
| K251402 | LIA-1 Catheter (542-1) | Leadoptik, Inc. | 12/19/2025 | KTI |
| K251730 | LIA Console (542-7) | Leadoptik, Inc. | 12/19/2025 | NQQ |
| K253577 | IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) |
Medicrea International S.A.S. (Medtronic) |
12/19/2025 | MAX |
| K250864 | MatriDerm Plus+ Bi-Layer | Medskin Solutions Dr. Suwelack AG |
12/19/2025 | KGN |
| K253409 | C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) |
Medtronic, Inc. | 12/19/2025 | DQY |
| K252892 | SCOUT MD Surgical Guidance System |
Merit Medical Systems, Inc. |
12/19/2025 | NEU |
| K252781 | MSFX MIKRON PEEK CAGES | Mikron Makina Sanayi VE Tic. Ltd. Sti. |
12/19/2025 | ODP |
| K251143 | Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) |
Ningbo Ranor Medical Science & Technology Co., Ltd. |
12/19/2025 | DXN |
| K251037 | Rectal Applicator | Nucletron B.V. | 12/19/2025 | JAQ |
| K232365 | Vivo 45 LS | Oconnell Regulatory Consultants, Inc. |
12/19/2025 | CBK |
| K253161 | Balanced Knee System TriMax Porous Femoral Components |
Ortho Development Corp. | 12/19/2025 | MBH |
| K253613 | Monkey Rings External Ring Fixation System |
Paragon 28, Inc. | 12/19/2025 | KTT |
| K251572 | Erapid With Etrack System | Pari Respiratory Equipment, Inc. |
12/19/2025 | CAF |
| K250976 | Airbile-100 | Poskom Co., Ltd. | 12/19/2025 | IZL |
| K252167 | Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) |
Qingdao Bright Moon Biomedical Materials Co., Ltd. |
12/19/2025 | FRO |
| K252863 | ClearCalc Model RADCA V2.6 | Radformation, Inc. | 12/19/2025 | MUJ |
| K253733 | STAR Apollo™ Mapping System | Rhythm AI, Ltd. | 12/19/2025 | DQK |
| K250998 | CO2 Laser Therapy System (Model: LFS-D9U) |
Sanhe Lefis Electronics Co., Ltd. |
12/19/2025 | GEX |
| K251077 | JOULE 1064nm System And Accessories |
Sciton, Inc. | 12/19/2025 | GEX |
| K252780 | LCD Monitor (CL1902A, CL2103F) | Shenzhen Beacon Display Technology Co., Ltd. |
12/19/2025 | PGY |
| K253054 | LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) |
Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. |
12/19/2025 | OHS |
| K251751 | Spo2 Sensor CSS032D | Shenzhen Ykd Technology Co., Ltd. |
12/19/2025 | DQA |
| K252838 | MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise |
Siemens Healthcare GmbH | 12/19/2025 | LNH |
| K253616 | ProtekDilate Vascular Access Kit |
Sorin Group Italia S.R.L. |
12/19/2025 | DRE |
| K253373 | Southern Craniomaxillofacial (CMF) System |
Southern Medical (Pty) , Ltd. |
12/19/2025 | JEY |
| K253202 | Hoffmann LRF System | Stryker GmbH | 12/19/2025 | KTT |
| K253086 | LED Light Therapy Device (Models: SG-FM, SG-FE) |
Sunglor Technology Co., Ltd. |
12/19/2025 | OHS |
| K250314 | Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer |
Surgical Instrument Service and Savings, Inc. |
12/19/2025 | PNE |
| K252670 | Alzevita | TOPIA MEDTECH LIMITED | 12/19/2025 | QIH |
| K251074 | Tru Liver Health Test Panel | Truvian Health | 12/19/2025 | CJE |
| K251011 | Chiavaye Personal Moisturizer | Unipack, LLC | 12/19/2025 | NUC |
| K252877 | SANDRO Dual | Wontech Co., Ltd. | 12/19/2025 | GEX |
| K253516 | Assert-IQ (DM5100) | Abbott Medical | 12/18/2025 | MXD |
| K250914 | MediAI-BA | Crescom Co., Ltd. | 12/18/2025 | QIH |
| K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) |
Edwards Lifesciences | 12/18/2025 | DQK |
| K252956 | Helo Thrombectomy System | Endovascular Engineering, Inc. |
12/18/2025 | QEW |
| K253915 | MOVIVA® Hybrid Ablation Probe | Erbe Elektromedizin GmbH | 12/18/2025 | GEI |
| K253518 | FX CorAL 40; FX CorAL 50 | Fresenius Medical Care Renal Therapies Group, LLC |
12/18/2025 | KDI |
| K252793 | ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C) |
Jiangsu Jiyuan Medical Technology Co., Ltd. |
12/18/2025 | HIH |
| K253758 | Dental Cone; Dental Sponge | Medizin Produkte Neustadt GmbH (Mpn) |
12/18/2025 | OLR |
| K251915 | Amethyst HP PTA OTW 0.035 Catheter |
Natec Medical , Ltd. | 12/18/2025 | LIT |
| K250993 | Single Use Cytology Brush V (BC-V600P-3010) |
Olympus Medical Systems Corporation |
12/18/2025 | FDX |
| K251562 | OTSCneo System Set (100.03n-14n, 100.27n-31n) |
Ovesco Endoscopy AG | 12/18/2025 | PKL |
| K252976 | Park Dental Nylon MAD | Park Dental Research Corp. |
12/18/2025 | LRK |
| K252071 | RefleXion Medical Radiotherapy System, Reflexion X2 |
Reflexion Medical, Inc. | 12/18/2025 | QVA |
| K252320 | SIMDA Abutments | Simda Co., Ltd. | 12/18/2025 | NHA |
| K252402 | Midline Catheter | Terumo Medical Products (Hangzhou) Co., Ltd. |
12/18/2025 | PND |
| K252348 | Tomey Optical Biometer OA-2000 (OA-2000) |
Tomey Corporation | 12/18/2025 | MXK |
| K252235 | PVAD IQ Software | Ultrasight , Ltd. | 12/18/2025 | QIH |
| K252417 | Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) |
Abbott Medical | 12/17/2025 | DQY |
| K252191 | BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System |
Bonebridge AG | 12/17/2025 | HRS |
| K253710 | Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System |
Dexcom, Inc. | 12/17/2025 | QBJ |
| K252518 | DuoprossTM Smart Cap (Type I) | Duopross Meditech Corporate |
12/17/2025 | FMF |
| K252739 | ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T) |
Ethicon Endo-Surgery, LLC |
12/17/2025 | GDW |
| K253093 | Vital™ Spinal Fixation System |
Highridge Medical, LLC | 12/17/2025 | NKB |
| K252508 | Intri26 Introducer Sheath | Inari Medical, Inc. | 12/17/2025 | DYB |
| K252922 | Neosoma Brain Mets | Neosoma, Inc. | 12/17/2025 | QIH |
| K253839 | Elecsys Anti-SARS-CoV-2 | Roche Diagnostics | 12/17/2025 | QVP |
| K253721 | KHEIRON® Spinal Fixation System, Including Patient Specific K-ROD |
S.M.A.I.O | 12/17/2025 | NKB |
| K250854 | Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro) |
Shenzhen Comen Medical Instruments Co.,Ltd |
12/17/2025 | MHX |
| K252983 | Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) |
Shenzhen Goodwind Technology Development Co., Ltd. |
12/17/2025 | OHS |
| K252398 | SURFLO Hybria Closed System Safety IV Catheter |
Terumo Medical Products (Hangzhou) Co., Ltd. |
12/17/2025 | FOZ |
| K251416 | UltraSight Guidance | Ultrasight , Ltd. | 12/17/2025 | QJU |
| K253719 | Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons |
Unibeauty (Hubei) Technology Co., Ltd. |
12/17/2025 | HEB |
| K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) |
Baxter Healthcare Corporation |
12/16/2025 | DXQ |
| K252111 | Versius Surgical System (Versius Plus) |
Cmr Surgical Limited | 12/16/2025 | SCV |
| K253118 | Companion Spine DIAM™ Instrumentation |
Companion Spine France | 12/16/2025 | QLR |
| K250925 | ADVIA Centaur Cytokeratin Fragment 21-1 |
Fujirebio Diagnostics,Inc. |
12/16/2025 | OVK |
| K253620 | TroClose 1200 | Gordian Surgical, Ltd. | 12/16/2025 | GAM |
| K251951 | Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F) |
Guangzhou Red Pine Medical Instrument Co., Ltd. |
12/16/2025 | FGB |
| K251763 | IRISeg | Intuitive Surgical, Inc. | 12/16/2025 | QIH |
| K251256 | PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) |
Pentax of America, Inc. | 12/16/2025 | FDS |
| K252940 | VR® Personal Protective Level 3 Gown (VR Gowns) |
PolyConversions, Inc. | 12/16/2025 | QPC |
| K252204 | Prolaio Evo2peak Module (Version 1.0) |
Prolaio, Inc. | 12/16/2025 | PPW |
| K252268 | V Series Portable Oxygen Concentrator (V5, V5C, V6, V6C) |
Shenzhen Harveymed Technology Co., Ltd. |
12/16/2025 | CAW |
| K251771 | Cambridge Partial Knee | Signature Orthopaedics Pty, Ltd. |
12/16/2025 | HSX |
| K251893 | SKAN C PULSAR | Skanray Technologies Limited |
12/16/2025 | OWB |
| K252373 | BioFlo Hybrid PICC With ENDEXO Technology And PASV Valve Technology; BioFlo PICC With ENDEXO Technology And PASV Valve Technology; BioFlo PICC With ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC With PASV Valve Technology; Xcela Hybrid PICC With PASV Valve Technology |
Spectrum Vascular | 12/16/2025 | LJS |
| K252919 | IDENTIFY (5.0) | Varian Medical Systems, Inc. |
12/16/2025 | IYE |
| K252468 | Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope Camera System (GY-AIO-121) |
Zhejiang Geyi Medical Instrument Co., Ltd. |
12/16/2025 | FGB |
| K253741 | V•Stick™ Vascular Access Set |
Argon Medical Devices, Inc. |
12/15/2025 | DYB |
| K252574 | Erchonia CLX (Model # CFL) | Erchonia Corporation | 12/15/2025 | OLI |
| K253403 | FemVue® Controlled Saline-Air Device (FSA-300) |
Femasys, Inc. | 12/15/2025 | LKF |
| K252935 | Hybrid Personal Lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml) |
Foshan Pingchuang Medical Technology Co., Ltd. |
12/15/2025 | NUC |
| K252898 | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper |
Howmedica Osteonics Corp., Dba Stryker Orthopaedics |
12/15/2025 | KRO |
| K253677 | Tembo Embolic System | Instylla, Inc. | 12/15/2025 | KRD |
| K252675 | Da Vinci SP Surgical System (SP1098) |
Intuitive Surgical, Inc. | 12/15/2025 | NAY |
| K250319 | MFUSE (MS001) | Machina Medical, Inc. | 12/15/2025 | QSY |
| K252950 | Paradigm System | Proprio, Inc. | 12/15/2025 | OLO |
| K251770 | SleepRes PAP System | Sleepres, Inc. | 12/15/2025 | BZD |
| K253101 | HyperVue™ Imaging System - Integrated |
Spectrawave, Inc. | 12/15/2025 | NQQ |
| K251302 | OptiMesh Multiplanar Expandable Interbody Fusion System |
Spineology, Inc. | 12/15/2025 | OQB |
| K250851 | Hypnos (369054-200) | Cadwell Industries, Inc. | 12/14/2025 | OLZ |
| K250488 | Cerynë Intimate Care | Ansella Therapeutics | 12/12/2025 | NUC |
| K252681 | EnCor EnCompass™ Breast Biopsy And Tissue Removal System |
Bard Peripheral Vascular, Inc. |
12/12/2025 | KNW |
| K250974 | Bio Arterial Deluxe (IC-BAP-DX) |
Bio Compression Systems, Inc. |
12/12/2025 | JOW |
| K252391 | Revi System | Bluewind Medical , Ltd. | 12/12/2025 | QXM |
| K242817 | Jason Membrane | Botiss Biomaterials GmbH | 12/12/2025 | NPL |
| K251989 | VizMark Preloaded Tissue Marker Device (VM-0001) |
Breast-Med, Inc. | 12/12/2025 | NEU |
| K253609 | TRAUMAGEL® 2.0 Hemostatic Gel | Cresilon, Inc. | 12/12/2025 | QSY |
| K252273 | Therapy US | Dmc Importação E Exportação DE Equipamentos Ltda |
12/12/2025 | NHN |
| K250821 | Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR And Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073) |
Eurosets Srl | 12/12/2025 | DTZ |
| K251089 | EXEL Disposable Syringe; EXEL Disposable Syringe With Needle; EXEL Disposable Syringe With Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle |
Exelint International, Co. |
12/12/2025 | FMF |
| K250863 | FUJIFILM Ultrasonic Endoscope EB-710US |
Fujifilm Corporation | 12/12/2025 | EOQ |
| K251177 | Self-Seal Sterilization Pouch And Roll |
Guangdong Maidi Medical Co., Ltd. |
12/12/2025 | FRG |
| K253489 | Swoop® Portable MR Imaging® System |
Hyperfine, Inc. | 12/12/2025 | LNH |
| K251085 | Ihealth Flu A&B/COVID-19/RSV Rapid Test; Ihealth Flu A&B/COVID-19/RSV Rapid Test Pro |
Ihealth Labs, Inc. | 12/12/2025 | SCA |
| K251092 | Ihealth Flu A&B/COVID-19 Rapid Test; Ihealth Flu A&B/COVID-19 Rapid Test Pro |
Ihealth Labs, Inc. | 12/12/2025 | SCA |
| K252090 | Pterygoid Indication For GM Helix Implants |
JJGC Indústria e Comércio de Materiais Dentários S.A. |
12/12/2025 | DZE |
| K252745 | Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2 .5/Novo-R-0.60-1.8/Novo-R-0.40 -1.8) |
Micro-Energy Medical Technology Co., Ltd. |
12/12/2025 | GEX |
| K252120 | Fundus On Phone Non Mydriatic (FOP NM-10) |
Remidio Innovative Solutions Private Limited |
12/12/2025 | HKI |
| K252785 | TopCEM Vigor SA Self-Adhesive Resin Cement |
Rizhao Huge Biomaterials Company, Ltd. |
12/12/2025 | EMA |
| K250847 | VaporShield | Vault Paragon Group, Inc. |
12/12/2025 | MEG |
| K253749 | Affixus® Natural Nail® Proximal Humeral System |
Zimmer Switzerland Manufacturing GmbH |
12/12/2025 | HSB |
| K253200 | Cervical Spine Truss System - Stand Alone (CSTS-SA) |
4Web Medical, Inc. | 12/11/2025 | OVE |
| K252897 | APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw); APS Osteotomy Fixation System (0850-4302-xx / 5.0mm Locking Screw); APS Osteotomy Fixation System (0701-xx10(1)-05 / Proximal Medial Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0701-xx60(1)-0x / Proximal Medial Tibial Osteotomy Locking Plate, Small); APS Osteotomy Fixation System (0702-xx00(1)-03 / Proximal Lateral Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0501-xx00(1)-04 / Dista |
A Plus Biotechnology Co., Ltd. |
12/11/2025 | HRS |
| K252997 | HyperFlex® Bunion Correction System |
Hyperflex Medical | 12/11/2025 | HRS |
| K250988 | KLS Martin Pure Pectus System | KLS- Martin L.P. | 12/11/2025 | HRS |
| K252482 | CogNet AI-MT+ | Medcognetics, Inc. | 12/11/2025 | QFM |
| K253141 | DeepRhythmAI | Medicalgorithmics S.A. | 12/11/2025 | DQK |
| K251883 | MIM – LesionID Pro | Mim Software, Inc. | 12/11/2025 | LLZ |
| K252941 | HALYARD* Adult Face Mask With SO SOFT* Lining And SO SOFT* Earloops |
O&M Halyard, Inc. | 12/11/2025 | FXX |
| K252694 | Target Detachable Coil | Stryker Neurovascular | 12/11/2025 | HCG |
| K251598 | Intellidrop | Brainspace, Inc. | 12/10/2025 | JXG |
| K252497 | SANSA HSAT | Huxley Medical | 12/10/2025 | MNR |
| K252826 | ARIX Femur Nail System | Jeil Medical Corporation | 12/10/2025 | HSB |
| K250192 | Verisafe Safety Retractable Insulin Syringes |
Promisemed Hangzhou Meditech Co., Ltd. |
12/10/2025 | FMF |
| K252343 | Atlantis® Abutments In Titanium |
Dentsply Sirona | 12/09/2025 | NHA |
| K250805 | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) |
Devilbiss Healthcare, LLC |
12/09/2025 | CAW |
| K250742 | Focused Cryotherapy System | Focused Cryo, Inc. | 12/09/2025 | GEH |
| K251199 | Allia Moveo | Ge Medical Systems Scs | 12/09/2025 | OWB |
| K252154 | Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, And LGT-2320SP) |
Guangzhou Longest Medical Technology Co., Ltd. |
12/09/2025 | NGX |
| K243449 | INFINITT DPS | Infinitt Healthcare Co., Ltd. |
12/09/2025 | QKQ |
| K252808 | GlasIonomer FX-LC | Shofu Dental Corporation | 12/09/2025 | EMA |
| K253706 | Lancing Device (HH-XV-T) | Tianjin Huahong Technology Co., Ltd. |
12/09/2025 | QRL |
| K252294 | Fetal EchoScan (v1.2) | Brightheart | 12/08/2025 | POK |
| K251936 | Ceribell Delirium Monitor System |
Ceribell, Inc. | 12/08/2025 | NCG |
| K251829 | DeGen Medical Patient Specific Implant (PSI) System |
Degen Medical | 12/08/2025 | OVD |
| K252862 | Electric Wheelchair (DH01126) | Foshan Dahao Medical Technology Co., Ltd. |
12/08/2025 | ITI |
| K252994 | LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8) |
Guangdong Ace-Tec Co., Ltd. |
12/08/2025 | OHS |
| K250190 | Sequential Compression System (SCD600) |
Shenzhen Comen Medical Instruments Co.,Ltd |
12/08/2025 | JOW |
| K252789 | Glass Ceramic | Shenzhen Xiangtong Co., Ltd. |
12/08/2025 | EIH |
| K250258 | HeartBeam AIMIGo With 12-L ECG Synthesis Software System |
Heartbeam, Inc. | 12/08/2025 | DXH |
| K250711 | VSP Orthopedics System | 3D Systems, Inc. | 12/05/2025 | PBF |
| K252504 | Gastric Alimetry | Alimetry , Ltd. | 12/05/2025 | MYE |
| K252841 | REAL INTELLIGENCE™ CORI™ XT (CORI XT) |
Blue Belt Technologies, Inc. |
12/05/2025 | OLO |
| K251403 | Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc ) |
Dornier Medtech America Inc (Dmta) |
12/05/2025 | FAS |
| K251722 | ProSeal™ Transfer Injector (421120, 421130, 421140) |
Epic Medical Pte. , Ltd. | 12/05/2025 | ONB |
| K243438 | MEMO Patch M (MPT-E08R-UNC01) | HUINNO Co., Ltd. | 12/05/2025 | DXH |
| K252825 | Manual Wheelchair (W45) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. |
12/05/2025 | IOR |
| K252828 | Manual Wheelchair (W47) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. |
12/05/2025 | IOR |
| K251731 | KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612) |
Karl Storz SE & CO.KG | 12/05/2025 | EOQ |
| K250764 | SpineLinc Anterior Cervical Implant System |
Lincotek Medical | 12/05/2025 | ODP |
| K250780 | ARTAssistant | Manteia Technologies Co., Ltd. |
12/05/2025 | QKB |
| K252465 | Any-Core | Mediclus Co., Ltd. | 12/05/2025 | EBF |
| K252605 | Mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) |
Medspira, LLC | 12/05/2025 | FFX |
| K252494 | Electrically Powered Wheelchair (KZ301B) |
Nanjing Kangni Smart Technology Co., Ltd. |
12/05/2025 | ITI |
| K250512 | Augmented Gingival Matrix | Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. |
12/05/2025 | NPL |
| K252296 | OncoPatch | Oncopatch, Inc. | 12/05/2025 | KXK |
| K251514 | Overjet CBCT Assist | Overjet, Inc. | 12/05/2025 | QIH |
| K253868 | QuietLab Pro | QuietLab, LLC | 12/05/2025 | LRK |
| K250743 | Remvia NightGuard | Remvia | 12/05/2025 | MQC |
| K251657 | Personalized Therapy Comfort Settings (PTCS) |
ResMed Corp | 12/05/2025 | BZD |
| K252067 | Velora Acetabular System | Restor3D, Inc. | 12/05/2025 | LPH |
| K252151 | Els Unibond | Saremco Dental AG | 12/05/2025 | KLE |
| K252142 | Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) |
Shenzhen Siken 3D Technology Development Co., Ltd. |
12/05/2025 | OHS |
| K252498 | Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s /E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/ SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/ SU11C CU) |
Sonoscape Medical Corp. | 12/05/2025 | IYN |
| K251337 | Thermo Scientific Oxoid Gepotidacin Disc (10 Μg) GEP10 |
Thermo Fisher Scientific (Oxoid Ltd.) |
12/05/2025 | JTN |
| K250795 | PUREVUE™ FMS | W.O.M. World of Medicine GmbH |
12/05/2025 | HRX |
| K250791 | ASUS Ultrasound Imaging System (LU800 Series) |
Asustek Computer, Inc. | 12/04/2025 | IYN |
| K252126 | MitraPatch Mitral Valve Repair System |
Chawla Heart Technologies, LLC |
12/04/2025 | PAW |
| K251257 | Nset+ Stabilization Set [6426733]; Nset+ Stabilization Set With Nsyte Needle Free Connector (NFC) [6426731]; Nsyte Needle Free Connector (NFC) [6426727] |
Np Medical | 12/04/2025 | FPA |
| K250679 | FFX Facet Fixation System | Sc Medica | 12/04/2025 | MRW |
| K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII) |
Siemens Healthcare Diagnostics, Inc. |
12/04/2025 | JNL |
| K251943 | Spineology Navigation Instruments |
Spineology, Inc. | 12/04/2025 | OLO |
| K252596 | Tigon Medical Knotless And Dual Javelin All-Suture Anchors |
Tigon Medical | 12/04/2025 | MBI |
| K252429 | Vektor Computational ECG Mapping System (vMap®) |
Vektor Medical, Inc. | 12/04/2025 | DQK |
| K252588 | Mobility Scooter (T5) | Zhejiang Taotao Vehicle Co., Ltd. |
12/04/2025 | INI |
| K252213 | Bendit17 Microcatheter | Bend IT Technologies, Ltd. |
12/03/2025 | QJP |
| K251203 | AVIEW Lung Nodule CAD | Coreline Soft Co.,Ltd | 12/03/2025 | OEB |
| K250725 | Hugo™ RAS System | Covidien, LLC | 12/03/2025 | SCV |
| K251881 | HippoMind (v1.0) | Hippoclinic | 12/03/2025 | OLT |
| K251779 | Omnipod 5 Algorithm | Insulet Corporation | 12/03/2025 | QJI |
| K251601 | Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
12/03/2025 | IYN |
| K253293 | VitaloJAK Clinic (Model 7100) | Vitalograph , Ltd. | 12/03/2025 | DSH |
| K250692 | GentleBeam (GB1000) | Voxel Ray Solutions, LLC | 12/03/2025 | JAD |
| K250564 | Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) |
Yadu Medical (Henan) Co., Ltd. |
12/03/2025 | FYA |
| K250896 | Aura Wave | Aura Wellness, LLC | 12/02/2025 | SGT |
| K250884 | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe |
Becton, Dickinson and Company |
12/02/2025 | NGT |
| K252021 | Disposable Endoscopic Injection Needles |
Changzhou New Med Micro-Medtech Co., Ltd. |
12/02/2025 | FBK |
| K252069 | Da Vinci SP Surgical System (SP1098) |
Intuitive Surgical, Inc. | 12/02/2025 | NAY |
| K252103 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) |
Mighty Oak Medical | 12/02/2025 | |
| K251696 | Unimed Reusable SpO2 Sensors (-48 Series And -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series And -29 Series) (U410-29) |
Unimed Medical Supplies, Inc. |
12/01/2025 | DQA |
| K251691 | Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08) |
Unimed Medical Supplies, Inc. |
12/01/2025 | DQA |
| K253250 | Minuteman® G6 MIS Fusion Plate |
Spinal Simplicity, LLC | 12/01/2025 | PEK |
| K252786 | Led Light Phototherapy Bed (Pro 450/ GY-680A) |
Shenzhen Suyzeko Limited. |
12/01/2025 | OLI |
| K250713 | Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants |
Exactech, Inc. | 12/01/2025 | KWT |
| K251370 | Cartesion Prime (PCD-1000A/3) V10.21 |
Canon Medical Systems Corporation |
12/01/2025 | KPS |
| K252827 | IBP Cable Becton Dickinson (2606488); IBP Cable Edwards (2606489); IBP Cable Abbott, Medex (2606490); IBP Cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559) |
Drägerwerk AG & Co KGaA | 12/01/2025 | DSA |
| K252658 | Medical Diode Laser Systems (TR-B) |
Baoding Te'Anzhou Electronic Technology Co., Ltd. |
11/28/2025 | GEX |
| K252217 | CT VScore+ | Canon Medical Informatics, Inc. |
11/28/2025 | JAK |
| K253303 | Dendrite Imaging System | Dendrite Imaging, Inc. | 11/28/2025 | QDG |
| K250636 | Sophy Mini Monopressure Valve (SM1) |
Sophysa | 11/28/2025 | JXG |
| K252760 | Carriere® Motion Pro® Clear Bite Corrector |
Ortho Organizers, Inc. | 11/27/2025 | DYW |
| K251697 | Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip |
Acon Laboratories, Inc. | 11/26/2025 | GTY |
| K251674 | Fenom Flo™ FeNO Monitoring System |
Mgc Diagnostics Corporation |
11/26/2025 | MXA |
| K253168 | 0.014” Willow Guidewire | Arbor Endovascular, LLC | 11/26/2025 | MOF |
| K252248 | CEREC Tessera Abutment System | Dentsply Sirona | 11/26/2025 | NHA |
| K252388 | Vanquish Water Vapor Ablation Device |
Francis Medical, Inc. | 11/26/2025 | KNS |
| K253269 | OEC One CFD | Ge Hualun Medical Systems Co. , Ltd. |
11/26/2025 | OXO |
| K252260 | RELIEEV HSG Catheter (HSG7FA1) | Li Medical Corporation , Ltd. |
11/26/2025 | LKF |
| K242976 | Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection And Transport Device |
Medical Wire & Equipment Company (Bath), Ltd. |
11/26/2025 | JSM |
| K252355 | K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing |
Sb-Kawasumi Laboratories, Inc. |
11/26/2025 | PTI |
| K252000 | Udr Arria & Udr Aris | Shanghai United Imaging Healthcare Co., Ltd. |
11/26/2025 | KPR |
| K252405 | Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter |
Surgical Instrument Service and Savings, Inc. |
11/26/2025 | NLH |
| K251058 | Tru Kidney Health Test Panel; Tru Analyzer |
Truvian Health | 11/26/2025 | CGX |
| K252889 | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) |
Olympus Medical Systems Corporation |
11/25/2025 | KNS |
| K251401 | PennPET Explorer Positron Emission Tomograph |
Trustees of the University of Pennsylvania |
11/25/2025 | KPS |
| K252289 | Eva Scalp Cooling System | Stemtech Medical Devices Private Limited |
11/25/2025 | PMC |
| K253344 | BELLUS-Q | Speclipse., Inc. | 11/25/2025 | GEX |
| K253219 | LeafPure-Echo (LM-LPNdA) | Shenzhen Leaflife Technology Co., Ltd. |
11/25/2025 | GEX |
| K251798 | RCT700 | Ray Co., Ltd. | 11/25/2025 | OAS |
| K251550 | NX01 (NX01) | Naox Technologies Sas | 11/25/2025 | OMC |
| K250694 | Scaida BrainCT-ICH (v1.0) | Mlhealth 360 | 11/25/2025 | QAS |
| K252555 | Medusa Orthopedics Boa External Fixation System |
Medusa Orthopedics, LLC | 11/25/2025 | KTT |
| K253365 | LuxCreo Flexible Partial Denture Resin |
Luxcreo, Inc. | 11/25/2025 | EBI |
| K252762 | HALO AP Dx | Indica Labs, LLC | 11/25/2025 | QKQ |
| K252161 | Hushd Avera | Good Sleep CO Pte , Ltd. | 11/25/2025 | LRK |
| K252253 | Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® |
Geistlich Pharma AG | 11/25/2025 | NPL |
| K250635 | FEops HEARTguide Simulation Application |
Feops NV | 11/25/2025 | QQI |
| K253310 | 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30) |
Esaote, S.P.A. | 11/25/2025 | IYN |
| K252004 | Encore Night Guard | Encore Guards | 11/25/2025 | OBR |
| K253304 | IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C) |
Dongguan Lide Electric Appliance Co., Ltd. |
11/25/2025 | OHT |
| K251070 | Akura Thrombectomy System | Akura Medical | 11/25/2025 | QEW |
| K251932 | Spectra Platinum | Uzinmedicare Co., Ltd. | 11/25/2025 | HGX |
| K252610 | ZSFab Lumbar Interbody System | Zsfab, Inc. | 11/25/2025 | MAX |
| K252771 | Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150) |
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. |
11/24/2025 | GEX |
| K252787 | Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) |
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. |
11/24/2025 | GEX |
| K253407 | NeVa PV Thrombectomy Device | Vesalio, Inc. | 11/24/2025 | QEX |
| K250769 | Dakota LP System | Precision Spine, Inc. | 11/24/2025 | ODP |
| K251631 | The BAG Manual Resuscitator And Accessories |
Laerdal Medical AS | 11/24/2025 | BTM |
| K252328 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 |
Ge Medical Systems Ultrasound and Primary Care Diagnostics |
11/24/2025 | IYN |
| K250634 | BCM2-Body Composition Monitor | Fresenius Medical Care Renal Therapies Group, LLC |
11/24/2025 | DSB |
| K252704 | F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St) |
F Care Systems USA, LLC | 11/24/2025 | GEI |
| K242503 | Trilly Pediatric Oxygenator With Integrated Arterial Filter (US5232) |
Eurosets Srl | 11/24/2025 | DTZ |
| K252688 | Transcutaneous Electrical Nerve Stimulator (RJTENS-2) |
Bozhou Rongjian Medical Appliance Co., Ltd. |
11/24/2025 | NUH |
| K252509 | AlphaVac Multipurpose Mechanical Aspiration System F1885 |
AngioDynamics, Inc. | 11/24/2025 | QEZ |
| K252366 | A2z-unified-triage | A2z Radiology Ai, Inc. | 11/24/2025 | QAS |
| K250927 | KARL STORZ Cholangiography Set | Karl Storz SE & Co. KG | 11/22/2025 | GCJ |
| K251506 | Nelli (Version 7.11) | Neuro Event Labs OY | 11/21/2025 | POS |
| K250560 | BEE HA | Ngmedical GmbH | 11/21/2025 | ODP |
| K251607 | Oxygen Concentrator (J5A) | Foshan Kycare Medical Equipment Co., Ltd. |
11/21/2025 | CAW |
| K251856 | Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 |
Everyway Medical Instruments Co.,Ltd |
11/21/2025 | NUH |
| K252686 | EffortMed PEEK Cages & Corpectomy Cages |
Effortmed, LLC | 11/21/2025 | ODP |
| K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits And White Foam Accessory |
Deroyal Industries, Inc. | 11/21/2025 | OMP |
| K251205 | Atlantis® Abutments In Titanium For Straumann BLX And Neodent GM Implants |
Dentsply Sirona | 11/21/2025 | NHA |
| K252070 | Ceribell Infant Seizure Detection Software |
Ceribell, Inc. | 11/21/2025 | OMB |
| K250714 | FluoroDose Varnish | Centrix, Inc. | 11/21/2025 | LBH |
| K251293 | CardioVision | Icardio.Ai | 11/21/2025 | QUO |
| K252666 | Articulator Arthroscopic Bur | Joint Preservation Innovations, LLC |
11/21/2025 | HRX |
| K252696 | LEGACY | Phasor Health, LLC | 11/21/2025 | HBG |
| K251849 | StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) |
Staclear, Inc. | 11/21/2025 | QLY |
| K250700 | Pen Injector Needle 32.5 | Terumo Corporation | 11/21/2025 | FMI |
| K252687 | Manual Wheelchair (HM305-Air1, HM305-Air2) |
Suzhou Master Machinery Manufacturing Co.,Ltd |
11/21/2025 | IOR |
| K252590 | Powered Mobility Scooter (PMS105, GUT177, GCAT047) |
Intradin (Shanghai) Machinery Co., Ltd. |
11/21/2025 | INI |
| K251880 | Archy Dental Imaging | Archy Dental, Inc. | 11/21/2025 | LLZ |
| K253681 | TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000) |
Graphy, Inc. | 11/21/2025 | EBI |
| K253495 | Syngo.mr Applications (VB80) | Siemens Healthineers AG | 11/20/2025 | LLZ |
| K251365 | OptumSI Implant System | Si Solutions, LLC | 11/20/2025 | OUR |
| K252625 | The Response Ortho Smart Fixator - Hexapod System |
Response Ortho Solutions, LLC |
11/20/2025 | KTT |
| K251904 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01) |
Remington Medical, Inc. | 11/20/2025 | DPW |
| K253190 | CORUS-LX Implant | Providence Medical Technology, Inc. |
11/20/2025 | MRW |
| K242606 | Nuvis® Wireless HD Camera System (Nuvis-2K) |
Integrated Endoscopy, Inc. |
11/20/2025 | GCJ |
| K250643 | Disposable Polymer Ligation Clips |
Hangzhou Kangji Medical Instrument Co., Ltd. |
11/20/2025 | FZP |
| K253007 | Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S) |
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. |
11/20/2025 | GEX |
| K250963 | PlanOne 1 | Cosylab Jsc, Control System Laboratory |
11/20/2025 | MUJ |
| K253123 | CuRAS Hybrid | Classys, Inc. | 11/20/2025 | GEX |
| K251822 | MAGNETOM Free.Max; MAGNETOM Free.Star |
Siemens Shenzhen Magnetic Resonance , Ltd. |
11/20/2025 | LNH |
| K243753 | Cobas Liat Bordetella Panel Nucleic Acid Test |
Roche Molecular Systems, Inc. |
11/20/2025 | OZZ |
| K253070 | Namic Radial Arm Band, 23 Cm (DYNJRADBAND); Namic Radial Arm Band, 26 Cm (DYNJRADBANDL) |
Medline Industries, LP | 11/20/2025 | DXC |
| K253105 | HardyDisk AST Cefiderocol 30µg (FDC30) |
Hardy Diagnostics | 11/20/2025 | JTN |
| K253324 | UltraPrint-Dental Denture UV | Guangzhou Heygears IMC., Inc. |
11/20/2025 | EBI |
| K252884 | Guided Aarhus Applicator Set | Varian Medical Systems | 11/19/2025 | JAQ |
| K253073 | LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) |
Sunglor Technology Co., Ltd. |
11/19/2025 | OHS |
| K242603 | MyPAO SA Guides | Medacta International S.A. |
11/19/2025 | PBF |
| K250642 | LUOFUCON® Skin And Wound Cleanser (Spray, Mist, Squeeze, Bottle.) |
Huizhou Foryou Medical Devices Co, Ltd. |
11/19/2025 | FRO |
| K252661 | SternaFuse Ti Fixation System | Fusion Innovations, LLC | 11/19/2025 | HRS |
| K250651 | OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun |
Fisher &Paykel Healthcare , Ltd. |
11/19/2025 | SGR |
| K253197 | ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors |
Depuy Ireland UC | 11/19/2025 | JWH |
| K252642 | Microcurrent Facial Device (CEC101, EEI101) |
Shenzhen Dachi Communication Co., Ltd. |
11/19/2025 | OHS |
| K253035 | IPL Hair Removal Device (SYL001AZ, SYL002AZ) |
Gu'An Yeolight Smart Electronics Co., Ltd. |
11/19/2025 | OHT |
| K251910 | Focal One® | Edap Technomed, Inc. | 11/19/2025 | PLP |
| K250912 | IntelliSep Test | Cytovale, Inc. | 11/19/2025 | QUT |
| K251695 | Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06) |
Unimed Medical Supplies, Inc. |
11/18/2025 | DQA |
| K251693 | Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75) |
Unimed Medical Supplies, Inc. |
11/18/2025 | DQA |
| K252636 | Fluido Compact System | The Surgical Company International B.V. |
11/18/2025 | LGZ |
| K252521 | LifeStyles® HydraFeel Natural Rubber Latex Condom |
Suretex Limited | 11/18/2025 | HIS |
| K252582 | Inclusive® Titanium Abutments Compatible With: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems |
Prismatik Dentalcraft, Inc. |
11/18/2025 | NHA |
| K253423 | ToeJack MIS Bunion System | Nvision Biomedical Technologies, Inc. |
11/18/2025 | HRS |
| K253411 | Miniature Telescope For Urology (27033AA) |
KARL STORZ SE & CO. KG | 11/18/2025 | FGB |
| K252550 | SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx |
Guangzhou Wondfo Biotech Co., Ltd. |
11/18/2025 | NFT |
| K252729 | Universal Spinal System | Double Medical Technology, Inc. |
11/18/2025 | NKB |
| K252818 | Dexcom Smart Basal | Dexcom, Inc. | 11/18/2025 | QRX |
| K251191 | Collagen Dura Regeneration Membrane - Repair |
Collagen Matrix, Inc. | 11/18/2025 | GXQ |
| K243981 | Hexoskin Medical System (7100-00016) |
Carre Technologies, Inc. | 11/18/2025 | DXH |
| K252281 | Ulricheasyinject Max 2M (XD 10140); Ulricheasyinject Max 3 (XD 10150); Ulricheasyinject Max 3 (XD 10180) |
Ulrich GmbH & Co. KG | 11/18/2025 | IZQ |
| K251566 | TS-RF Generator (STS10) | Starmed Co., Ltd. | 11/17/2025 | GEI |
| K252086 | DTX Studio Assist | Nobel Biocare C/O Medicim NV |
11/17/2025 | MYN |
| K251141 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile Tested For Use With Chemotherapy Drugs And Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black Colored, Non-sterile Tested For Use With Chemotherapy Drugs And Fentanyl Citrate |
Mercator Medical (Thailand), Ltd. |
11/17/2025 | LZA |
| K250588 | Access Rubella IgG | Beckman Coulter, Inc. | 11/17/2025 | LFX |
| K253487 | ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc. |
11/17/2025 | IYN |
| K252792 | PM2™ System With ECGuide™ Connector |
Piccolo Medical, Inc. | 11/17/2025 | LJS |
| K252330 | DeepRESP | Nox Medical Ehf | 11/17/2025 | OLZ |
| K250501 | System Sophi | This AG | 11/14/2025 | HQC |
| K251659 | Mesh Nebulizer (H6) | Qingdao Future Medical Technology Co., Ltd. |
11/14/2025 | CAF |
| K251538 | Status™ COVID-19/Flu A&B | Princeton Biomeditech Corp |
11/14/2025 | SCA |
| K250525 | Second Opinion® Panoramic | Pearl, Inc. | 11/14/2025 | MYN |
| K251756 | Sterilization Trays | Paragon Implant Mfg., LLC |
11/14/2025 | KCT |
| K251821 | ARC-EX System | Onward Medical, Inc. | 11/14/2025 | SDO |
| K250865 | KLS Martin IPS Forearm System | Kls- Martin L.P. | 11/14/2025 | HRS |
| K252627 | Lyme-ID IgG Test; Bio-ID800 | Inanovate, Inc. | 11/14/2025 | LSR |
| K250471 | AquaC UNO H | Fresenius Medical Care Renal Therapies Group, LLC |
11/14/2025 | FIP |
| K251078 | AutoDensity | Eos Imaging | 11/14/2025 | QIH |
| K251872 | Biomoneta Avata Rx | Biomoneta Research Private Limited |
11/14/2025 | FRF |
| K252618 | IPL Hair Removal Device (I6 S1, I6 D1, I6 M1) |
Alovea Healthcare Co. , Ltd. |
11/14/2025 | OHT |
| K252592 | TELLTALE Electrosurgical Guidewire System |
Telltale, LLC | 11/13/2025 | SGO |
| K252949 | Geminus Volar Distal Radius Plating System |
Skeletal Dynamics, Inc. | 11/13/2025 | HRS |
| K251662 | Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506); Air Compression Therapy Device (ST-507) |
Shenzhen Future Electronic Co., Ltd. |
11/13/2025 | IRP |
| K251314 | Rosa® Knee System | Orthosoft Inc. (d/b/a) Zimmer CAS |
11/13/2025 | OLO |
| K251842 | Dental Computed Tomography X-ray System |
Fussen Technology Co., Ltd. |
11/13/2025 | OAS |
| K252308 | LED Beauty Mask (RLBXX) | Atop Lighting Co., Ltd. | 11/13/2025 | OHS |
| K253457 | ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc. |
11/13/2025 | IYN |
| K252829 | Powered Wheelchair (PL001-9001) |
Suzhou KD Intelligent Device Co., Ltd. |
11/12/2025 | ITI |
| K253290 | XSTAT P15 | Revmedx, Inc. | 11/12/2025 | PGZ |
| K252452 | PeekMed Web | Peek Health, S.A. | 11/12/2025 | QIH |
| K251336 | VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA) |
Olympus Medical Systems Corp. |
11/12/2025 | OWN |
| K252959 | WRISTAR MultiAx Distal Radius Kit |
Intrauma S.P.A | 11/12/2025 | HRS |
| K252271 | Hemoclip | Hangzhou Ags Medtech Co., Ltd. |
11/12/2025 | PKL |
| K243897 | PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture |
Ethicon, Inc. | 11/12/2025 | NEW |
| K251833 | EMPOWR Acetabular® Liner Extension |
Encore Medical, LP | 11/12/2025 | LPH |
| K243715 | Synthes Patient Specific Implants |
Synthes GmbH | 11/12/2025 | GXN |
| K252327 | CMORE® CT System; CMORE® CT System Navigated Instruments |
Icotec AG | 11/12/2025 | NKG |
| K252474 | Withings BeamO (SCT02) | Withings | 11/10/2025 | DPS |
| K251006 | NeVasc Aspiration System | Vesalio, Inc. | 11/10/2025 | NRY |
| K252570 | EzSensor HD, EzSensor UHD | Qpix Solutions, Inc. | 11/10/2025 | MUH |
