IFU is not found for this 510(k).
| 510(k) Number | Device Name | Applicant | Decision Date | Procode |
|---|---|---|---|---|
| K232507 | Aerogen®Solo Nebulizer System | Aerogen Ltd. | 05/10/2024 | CAF |
| K240479 | Access OV Monitor | Beckman Coulter, Inc | 05/10/2024 | LTK |
| K240365 | Bioceramic Root Repair Material (C-Root BP) |
Beijing C-Root Dental Medical Devices Co., Ltd. |
05/10/2024 | KIF |
| K233950 | Pureflow 402 (F00012067); Pureflow 406 (F00012068); Pureflow 401 (F00012069); Pureflow 400 (F00012070) |
Fresenius Medical Care Renal Therapies Group, LLC |
05/10/2024 | KPO |
| K233629 | APERTO Lucent MRI System | FUJIFILM Healthcare Americas Corporation |
05/10/2024 | LNH |
| K234023 | Oocyte Flushing & Retrieval Medium; Gamete Buffer |
Gimbo Medical Technology Shenzhen Co., Ltd. |
05/10/2024 | MQL |
| K240276 | PillCam™ Genius SB System With PillCam Software V9.7 And PillCam Cloud Reader Software |
Given Imaging Ltd. (d.b.a. Medtronic) |
05/10/2024 | NEZ |
| K240698 | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard |
Guangzhou Decheng Biotechnology Co., Ltd. |
05/10/2024 | DJG |
| K233277 | Filter Needle For Single Use | Hangzhou Qiantang Longyue Biotechnology Co., LTD |
05/10/2024 | FPB |
| K232410 | SmartChest | Milvue | 05/10/2024 | QFM |
| K233100 | QIAstat-Dx® Respiratory Panel Plus |
QIAGEN GmbH | 05/10/2024 | QOF |
| K232475 | Disposable Infusion Set With Needle |
Shandong Zhushi Pharmaceutical Group Co., Ltd |
05/10/2024 | FPA |
| K240374 | Ureterorenoscope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. |
05/10/2024 | FGB |
| K240699 | SCARLET® AC-Ti | Spineart SA | 05/10/2024 | OVE |
| K240708 | Organic Cotton Tampon; Organic Cotton PESCVcord Tampon |
Suzhou Borage Medical Technology Co., Ltd. |
05/10/2024 | HEB |
| K234079 | HyperSuture Extension Line | Threadstone L.L.C. | 05/10/2024 | GAT |
| K234112 | Customized Abutment | Arum Dentistry Co., Ltd. | 05/09/2024 | NHA |
| K240403 | Access BR Monitor | Beckman Coulter, Inc. | 05/09/2024 | MOI |
| K233418 | Biofourmis Everion+ (G2) | Biofourmis Singapore Pte. Ltd. |
05/09/2024 | MSX |
| K233982 | CEREGLIDE 92 Catheter System | Cerenovus Inc. | 05/09/2024 | QJP |
| K232025 | Hushd Pro Avera | Good Sleep Co Pte Ltd. | 05/09/2024 | LRK |
| K232477 | Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852) |
Jiangxi AOV Maternity & Baby Products Co., Ltd. |
05/09/2024 | HGX |
| K233602 | P200TE (A10700) | Optos Plc | 05/09/2024 | OBO |
| K240296 | Tulsa Pro System (Pad-105) | Profound Medical, Inc. | 05/09/2024 | PLP |
| K232468 | SC Medica FFX | SC Medica | 05/09/2024 | MRW |
| K232470 | Polyisoprene Extra Large Condom |
Suretex Limited | 05/09/2024 | MOL |
| K233967 | DePuy Synthes MatrixSTERNUM Fixation System |
Synthes GmbH | 05/09/2024 | HRS |
| K240495 | Flexible Fixation Device For Gynecological Applicators (GM11001960) |
Varian Medical Systems, Inc |
05/09/2024 | JAQ |
| K232976 | VUZE System | VUZE Medical Ltd. | 05/09/2024 | LLZ |
| K233918 | Dental Barrier And Sleeves | Yongqing Huaguan Dental Instruments Factory |
05/09/2024 | PEM |
| K233803 | UltraClear Laser System (N/A) | Acclaro Corporation | 05/08/2024 | GEX |
| K240964 | FLOW 90? Wand | ArthroCare Corporation | 05/08/2024 | GEI |
| K222292 | F&P Myairvo 3 | Fisher & Paykel Healthcare |
05/08/2024 | BTT |
| K233581 | VITROS Immunodiagnostic Products Total Ss-hcg II Reagent Pack |
Ortho Clinical Diagnostics |
05/08/2024 | DHA |
| K232649 | Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses |
Pegavision Corporation | 05/08/2024 | LPL |
| K240999 | Legend X Applicator VO | Pollogen Ltd. | 05/08/2024 | GEI |
| K241008 | Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece, Autoclavable (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr 5.0mm (R-10021); Standard Shaver 3.4mm (R-10012); Curved St |
Relign Corporation, Subsidiary of Zimmer Biomet |
05/08/2024 | GEI |
| K233695 | Medical HAL Lower Limb Type (HAL-ML) |
Cyberdyne Inc. | 05/07/2024 | PHL |
| K234018 | CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System |
Dentsply Sirona | 05/07/2024 | NHA |
| K232833 | HALO AP Dx | Indica Labs, Inc. | 05/07/2024 | PSY |
| K232486 | KARL STORZ Monopolar Resectoscopes With HF Cable |
Karl Storz SE & CO. KG | 05/07/2024 | FJL |
| K233864 | ASSURE Wearable ECG | Kestra Medical Technologies, Inc. |
05/07/2024 | MWJ |
| K231612 | Eve Patient Positioner System | Leo Cancer Care | 05/07/2024 | JAI |
| K234039 | AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260) |
Lexington Medical, Inc. | 05/07/2024 | GAG |
| K233766 | Geneo X Elite | Pollogen Ltd. | 05/07/2024 | PAY |
| K240954 | Shockwave Intravascular Lithotripsy (IVL) System With The Shockwave L6 Peripheral IVL Catheter |
Shockwave Medical, Inc. | 05/07/2024 | PPN |
| K240377 | LIFEPAK® ECG Cables | Stryker Physio-Control | 05/07/2024 | DSA |
| K232928 | DeepContour (V1.0) | Wisdom Technologies., Inc. |
05/07/2024 | QKB |
| K232493 | Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) |
Wuhan Huchuang Union Technology Co., Ltd. |
05/07/2024 | MQG |
| K234033 | ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) |
Boehringer Laboratories LLC |
05/06/2024 | KNT |
| K240392 | JAZZ Spinal System | Implanet | 05/06/2024 | NKB |
| K240007 | Solar Compact (G4-1) | Laborie Medical Technologies Corp. |
05/06/2024 | FFX |
| K232514 | MIM – Dose Analysis | MIM Software Inc. | 05/06/2024 | LLZ |
| K240685 | Salvo® Spine System | Spine Wave, Inc. | 05/06/2024 | NKB |
| K233800 | Vertos Mild Device Kit (MDK-0002) |
Vertos Medical Inc | 05/06/2024 | HRX |
| K233349 | Alinity M HSV 1 & 2 / VZV | Abbott Molecular Inc | 05/03/2024 | PGI |
| K232454 | Viral Transport Media (VTM) | ALB Luz | 05/03/2024 | JSM |
| K240800 | Access Intrinsic Factor Ab | Beckman Coulter Inc | 05/03/2024 | LIG |
| K234088 | Emily's Care Nourish Test System (Model 1) |
Lactation Lab Inc. | 05/03/2024 | QEI |
| K232416 | AUTION EYE AI-4510 Urine Particle Analysis System |
Arkray Inc. | 05/03/2024 | LKM |
| K232895 | B-Ultrasound Diagnostic System | Contec Medical Systems Co., Ltd. |
05/03/2024 | IYO |
| K240185 | Cypris Exact Suture Placement Device |
Cypris Medical | 05/03/2024 | GEJ |
| K232735 | EMA 3D | EMA Sleep Incorporated | 05/03/2024 | LRK |
| K233687 | ECHELON Synergy V10.0 | Fujifilm Healthcare Americas Corporation |
05/03/2024 | LNH |
| K233524 | Sleeved IC 2 Family; Sleeved IC 2 SWT (Name Not Finalized); Sleeved IC 2 Plus (Name Not Finalized); Sleeved IC 2 Pocket (Name Not Finalized); Sleeved IC 2 Plus Pocket (Name Not Finalized) |
Hollister Incorporated | 05/03/2024 | EZD |
| K233157 | VaporMAX LDD; MOJo LDD; MegaJOULE LDD |
InnovaQuartz LLC | 05/03/2024 | GEX |
| K234021 | Masimo Stork | Masimo Corporation | 05/03/2024 | QYU |
| K232733 | Mbrace Cable | Medacta International S.A. |
05/03/2024 | JDQ |
| K232365 | Vivo 45 LS | OConnell Regulatory Consultants, Inc. |
05/03/2024 | CBK |
| K232648 | RODEO Telescopic Nail | Orthofix SRL | 05/03/2024 | HSB |
| K232776 | Tablo® Hemodialysis System; TabloCart™ With Prefiltration Drawer |
Outset Medical, Inc. | 05/03/2024 | KDI |
| K232491 | CT 5300 | Philips Healthcare (Suzhou) Co., Ltd. |
05/03/2024 | JAK |
| K240126 | ProAM ALIF System | Pro Surgical, Inc. | 05/03/2024 | OVD |
| K240625 | CORUS Navigation Access System | Providence Medical Technology, Inc. |
05/03/2024 | OLO |
| K240919 | Silk Voice (SMI-04) | Sofregen Medical | 05/03/2024 | MIX |
| K232941 | Megaloop Button System | Suzhou Endophix Co., Ltd. |
05/03/2024 | MBI |
| K240297 | Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) |
US Medical Innovations, LLC |
05/03/2024 | OAB |
| K240940 | Vial2Bag Advanced® 20mm Admixture Device |
West Pharmaceutical Services, Inc. |
05/03/2024 | LHI |
| K240636 | HemoScreen Hematology Analyzer | PixCell Medical Technologies |
05/02/2024 | GKZ |
| K240037 | Revi™ System | BlueWind Medical Ltd. | 05/02/2024 | QXM |
| K232445 | CSF-4 (CSF-4) | CardiacSense | 05/02/2024 | DPS |
| K233752 | Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps |
CenterPoint Systems LLC | 05/02/2024 | FBN |
| K232908 | Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C) |
Contec Medical Systems Co., Ltd. |
05/02/2024 | IYN |
| K232464 | VereSee Optical Veres Needle System |
Freyja Healthcare, LLC | 05/02/2024 | HIF |
| K233857 | Neodent Implant System – Custom Abutments |
JJGC Indústria e Comércio de Materiais Dentários S.A. |
05/02/2024 | NHA |
| K233689 | Hope&Her Vaginal Dilators | Lujena, Inc. | 05/02/2024 | HDX |
| K240261 | Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027) |
Merit Medical Systems, Inc. |
05/02/2024 | KRD |
| K232902 | EVA15 Insufflator | Palliare Ltd. | 05/02/2024 | HIF |
| K240012 | Mobility Scooter (W3431) | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. |
05/02/2024 | INI |
| K240279 | VIDAS TBI (GFAP, UCH-L1) | Biomerieux Inc. | 05/01/2024 | QAT |
| K240900 | HOTWIRE™ RF Guidewire | Atraverse Medical | 05/01/2024 | DXF |
| K240829 | AuST Steerable Sheath | CenterPoint Systems LLC | 05/01/2024 | DYB |
| K233203 | Soft Tissue Augmentation Resorbable Matrix |
Collagen Matrix, Inc. | 05/01/2024 | NPL |
| K233284 | Vial Adapter With Filter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd |
05/01/2024 | LHI |
| K240986 | Cold Compression | JKH Health Co., Ltd. | 05/01/2024 | IRP |
| K232370 | Percutaneous Nephroscope System |
Karl Storz SE & Co. Kg | 05/01/2024 | FGA |
| K240925 | DuraGraft Vascular Conduit Solution |
Marizyme | 05/01/2024 | QEJ |
| K234113 | MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box |
Medimaging Integrated Solution, Inc. (MiiS) |
05/01/2024 | EOQ |
| K232858 | ORskin Blue | Megabay S.A. | 05/01/2024 | GEX |
| K240882 | BruxZir® Esthetic | Prismatik Dentalcraft, Inc. |
05/01/2024 | EIH |
| K233516 | Tono-Vera® Tonometer And Ocu-Dot® Tonometer Probes (16305, 16306, 16318) |
Reichert, Inc. | 05/01/2024 | HKY |
| K233513 | Remex Spine Surgery Navigation System II |
Remex Medical Corp. | 05/01/2024 | OLO |
| K231722 | SmarTooth | Smartooth Co., Ltd. | 05/01/2024 | NBL |
| K240621 | Morpheus® Moldable; Agilon® Moldable |
Biogennix, LLC | 04/30/2024 | MQV |
| K233231 | Dental Implants And Abutments | Ditron Dental LTD | 04/30/2024 | DZE |
| K233122 | High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500 ,G600,G700,G700L,G800,G800L) |
Litu Tech Ltd. | 04/30/2024 | EFB |
| K232889 | METICULY Patient-specific Titanium Maxillofacial Mesh Implant |
Meticuly Co., Ltd. | 04/30/2024 | JEY |
| K232528 | Protective Cap | Neobiotech Co., Ltd. | 04/30/2024 | NHA |
| K240156 | LIFEPAK® Invasive Pressure Adapter Cable (Interfaces With ICU Medical Transpack IV Invasive Pressure Transducers (or Equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces With Edwards Lifesciences TruWave Invasive Pressure Transducers (or Equivalent)) (11230-000024) |
Physio-Control, Inc. | 04/30/2024 | DSA |
| K240118 | Picosecond Nd:YAG Laser System | Smedtrum Medical Technology Co., Ltd. |
04/30/2024 | GEX |
| K232923 | Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0) |
Varian Medical Systems Inc. |
04/30/2024 | IYE |
| K233403 | Flexset System | Zeto, Inc. | 04/30/2024 | GWQ |
| K233939 | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System |
Boston Scientific | 04/29/2024 | ESW |
| K240248 | Volnewmer™ | Classys Inc. | 04/29/2024 | GEI |
| K240568 | DuraPro™ Oscillating System | Globus Medical, Inc. | 04/29/2024 | OLO |
| K240102 | Blood Pressure Monitor (TMB-2287-B) |
Guangdong Transtek Medical Electronics Co., Ltd. |
04/29/2024 | DXN |
| K240062 | ARVIS® Shoulder | Insight Medical Systems, Inc. |
04/29/2024 | OLO |
| K240591 | Restor3d Kinos Axiom Total Ankle System |
restor3d, Inc. | 04/29/2024 | HSN |
| K240584 | XTRA Autotransfusion System (with XTRA Bowl Sets) |
Sorin group Italia S.r.l. |
04/29/2024 | CAC |
| K240526 | POWEReam Xia/Serrato | Stryker Instruments | 04/29/2024 | NKB |
| K233699 | SubtleREFORMAT (1.x) | Subtle Medical, Inc. | 04/29/2024 | LLZ |
| K232511 | Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) |
Surgical Instrument Service and Savings Inc. |
04/29/2024 | NUJ |
| K240091 | NB Mini Implant System | Arum Dentistry Co., Ltd. | 04/26/2024 | DZE |
| K232298 | DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl |
Canon Inc. | 04/26/2024 | OWB |
| K240872 | Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System |
Clariance | 04/26/2024 | NKB |
| K233703 | Bone Anchor (NGS-BA-01) | ClearPoint Neuro Inc. | 04/26/2024 | HAW |
| K240324 | EMPOWR Revision Symmetric Knee Cones |
Encore Medical, L.P. (dba Enovis) |
04/26/2024 | JWH |
| K240879 | EsophyX Z+ Device With SerosaFuse Fasteners And Accessories |
EndoGastric Solutions, Inc. |
04/26/2024 | ODE |
| K233583 | FCT Istream Phase 1 | FUJIFILM Healthcare Americas Corporation |
04/26/2024 | JAK |
| K233873 | XLO Brand Of Locking Distal Humerus Plating System |
Ortho Life Systems Private Limited |
04/26/2024 | HRS |
| K232261 | TME Temporary Myocardial Electrode |
Osypka AG | 04/26/2024 | LDF |
| K221688 | ASTar BC G- Kit And ASTar Instrument |
Q-linea AB | 04/26/2024 | SAN |
| K232302 | Pocket III | Quantel Medical | 04/26/2024 | IYO |
| K220272 | Cobas Pulse Blood Glucose Monitoring System |
Roche Diagnostics | 04/26/2024 | PZI |
| K240566 | Reef L Interbody System; WaveForm L Interbody System |
SeaSpine Orthopedics Corporation |
04/26/2024 | MAX |
| K233673 | Umr Jupiter | Shanghai United Imaging Healthcare Co., Ltd |
04/26/2024 | LNH |
| K232435 | Rhinolaryngoscope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. |
04/26/2024 | EOB |
| K232799 | Syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. |
04/26/2024 | MUJ |
| K240406 | Sonio Detect | Sonio | 04/26/2024 | IYN |
| K232317 | UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips |
URIT Medical Electronic Co., Ltd. |
04/26/2024 | JIO |
| K240299 | Persona The Personalized Knee System (Persona OsseoTi 3-Peg Patella) |
Zimmer, Inc. | 04/26/2024 | MBH |
| K232038 | BioStar Single Use Transbronchial Aspiration Needle |
Broncus Medical, Inc. | 04/26/2024 | EOQ |
| K232405 | ENDOFIX EXO | AKTORmed GmbH | 04/25/2024 | OCV |
| K240846 | CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System And High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System And High V+® Bone Cement |
CarboFix Orthopedics Ltd. |
04/25/2024 | NKB |
| K240535 | Digital ClarusScope System; Digital NeuroPEN System |
Clarus Medical, LLC | 04/25/2024 | HRX |
| K232357 | Copan Universal Transport Medium (UTM-RT) System |
Copan Italia S.p.A. | 04/25/2024 | JSM |
| K231142 | Temporis, Irix Plus | DWS s.r.l. | 04/25/2024 | EBF |
| K233810 | Portrait VSM | GE Medical Systems Information Technologies, Inc. |
04/25/2024 | MWI |
| K232796 | LUOFUCON® Collagen Particles (Collagen Wound Dressing) |
Huizhou Foryou Medical Devices Co., Ltd. |
04/25/2024 | KGN |
| K232331 | InVision Precision LVEF (LVEF) | InVision Medical Technology Corporation |
04/25/2024 | QIH |
| K232246 | 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture |
M/s. Meril Endo Surgery Private Limited |
04/25/2024 | NEW |
| K233308 | Air Motor (Model Name: FX204 M4); Air Motor (Model Name: M205) |
NAKANISHI INC. | 04/25/2024 | EFB |
| K232805 | Kronos Electrocautery Device | Single Pass, Inc. | 04/25/2024 | GEI |
| K234065 | CDI OneView Monitoring System | Terumo Cardiovascular Systems Corporation |
04/25/2024 | DRY |
| K240855 | Dental Cone-beam Computed Tomography |
Yian Medical Technology (Haining) Co., Ltd. |
04/25/2024 | OAS |
| K234056 | Canturio® Se (Canturio Smart Extension) |
Canary Medical USA LLC | 04/24/2024 | QPP |
| K233764 | SSS-NX (Serum Substitute Supplement-NX) |
FUJIFILM Irvine Scientific |
04/24/2024 | MQL |
| K232181 | Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) |
Hebei JT Medical Co., Ltd. |
04/24/2024 | NGX |
| K234025 | 22.2mm BIOLOX® Delta Ceramic V40™ Femoral Heads |
Howmedica Osteonics Corp. dba Stryker Orthopaedics |
04/24/2024 | LZO |
| K233172 | NextAR™ Spine Platform | Medacta International S.A. |
04/24/2024 | OLO |
| K240623 | Omnia Medical TiBrid™-SA System |
Omnia Medical, LLC | 04/24/2024 | OVD |
| K240839 | OpenRad Cloud | OpenRad Services UK Ltd | 04/24/2024 | LLZ |
| K240822 | Image Management V15 | Philips Medical Systems Technologies |
04/24/2024 | LLZ |
| K240850 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems |
Philips Ultrasound LLC | 04/24/2024 | IYN |
| K240319 | DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) |
Pro Med Instruments GmbH | 04/24/2024 | HBL |
| K240093 | IPL Home Use Hair Removal Device (SJ15) |
Shenzhen Shuge Medical Beauty Devices Co., Ltd. |
04/24/2024 | OHT |
| K240208 | DESS Dental Smart Solutions | Terrats Medical SL | 04/24/2024 | NHA |
| K240058 | AEYE-DS | AEYE Health Inc. | 04/23/2024 | PIB |
| K240816 | MeDioStar | Asclepion Laser Technologies GmbH |
04/23/2024 | GEX |
| K233849 | BTL-499 | BTL Industries, Inc. | 04/23/2024 | GEI |
| K240902 | Dexcom G7 Continuous Glucose Monitoring System |
Dexcom Inc. | 04/23/2024 | QBJ |
| K240518 | Swiftpro™ System | Emblation Limited | 04/23/2024 | NEY |
| K231699 | QUANTUM® Patient Specific Instrumentation (PSI) System |
In2Bones SAS | 04/23/2024 | HSN |
| K234107 | Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) |
Laborie Medical Technologies Corp. |
04/23/2024 | KLA |
| K234147 | ReNew XR Handpiece, 25cm, With Reference Markings (3943M); ReNew XR Handpiece, 34cm, With Reference Markings (3941M); ReNew XR Handpiece, 42cm, With Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, With Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, With Referenc |
Microline Surgical, Inc. | 04/23/2024 | GEI |
| K233948 | Provisio™ SLT IVUS™ System | Provisio Medical, Inc. | 04/23/2024 | OBJ |
| K233329 | Route 92 Medical Full Length 054 Reperfusion System And Aspiration Tubing Set |
Route 92 Medical, Inc. | 04/23/2024 | NRY |
| K222958 | Mjoule RF System And Accessories |
Sciton, Inc. | 04/23/2024 | GEI |
| K233537 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System |
Abbott Diabetes Care Inc. |
04/23/2024 | QBJ |
| K233966 | Anterior Spine Truss System-Stand Alone (ASTS-SA) |
4WEB Medical, Inc. | 04/22/2024 | OVD |
| K233311 | Acumed Wrist Plating System | Acumed LLC | 04/22/2024 | HRS |
| K234041 | Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monit |
Andon Health Co Ltd | 04/22/2024 | DXN |
| K240182 | Access EPO | Beckman Coulter Inc | 04/22/2024 | GGT |
| K223515 | MamaLift Plus | Curio Digital Therapeutics Inc. |
04/22/2024 | SAP |
| K233582 | Rapid | iSchema View Inc. | 04/22/2024 | LLZ |
| K240115 | Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, NuewaI8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
04/22/2024 | IYN |
| K234068 | ART-Plan (v.2.2.0) | Therapanacea SAS | 04/22/2024 | MUJ |
| K232319 | Black Pearl Nitrile Examination Glove |
UG Global Resources Sdn. Bhd. |
04/22/2024 | LZA |
| K232149 | BowTie™ SI Joint Fusion System |
SAIL Fusion, LLC | 04/20/2024 | OUR |
| K233373 | Flowflex® Plus COVID-19 Home Test |
Acon Laboratories, Inc. | 04/19/2024 | QYT |
| K234092 | SafeOp 3: Neural Informatix Systeem |
Alphatec Spine, Inc. | 04/19/2024 | GWF |
| K233106 | AccuCath Ace™ Intravascular Catheter |
Bard Access Systems, Inc. (C.R. Bard, Inc.) |
04/19/2024 | FOZ |
| K230120 | KeYi Total Knee System | Beijing KeYi Medical Device Technology Co., Ltd. |
04/19/2024 | JWH |
| K232962 | Patient Monitor (iX10, Ix12, Ix15) |
Edan Instruments, Inc | 04/19/2024 | MHX |
| K234073 | ICE Aspiration System | Expanse Medical Inc. | 04/19/2024 | QEW |
| K232204 | ReyaGel (RG03 - MTP Gel 3mL) | FetTech | 04/19/2024 | KGN |
| K240378 | FAQ™ 201, FAQ™ 202 | Foreo Inc. | 04/19/2024 | OHS |
| K232377 | Healgen Rapid COVID-19 Antigen Test |
Healgen Scientific LLC | 04/19/2024 | QVF |
| K232216 | Hemoblock_S (Prescription); Hemoblock_S (OTC) |
Incore Co., Ltd. | 04/19/2024 | QSY |
| K234119 | UniSpace® Stand-Alone C Cage | Innosys Co., Ltd. | 04/19/2024 | OVE |
| K240781 | SKOUT® System | Iterative Scopes, Inc. | 04/19/2024 | QNP |
| K240508 | Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) |
Laclede, Inc. | 04/19/2024 | LFD |
| K232105 | APTUS Foot System 2.8-3.5 | Medartis AG | 04/19/2024 | HRS |
| K240534 | Bio-Medicus Life Support Catheter And Introducer |
Medtronic Inc. | 04/19/2024 | QHW |
| K233046 | Electrical Neuromuscular Stimulator, Cure Trio |
Oriental Inspiration Limited |
04/19/2024 | NUH |
| K240753 | Miro3D Fibers Wound Matrix | Reprise Biomedical, Inc. | 04/19/2024 | KGN |
| K232566 | NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System |
SeaSpine Orthopedics Corporation |
04/19/2024 | NKB |
| K232259 | Patriot-SI Posterior Implant System |
Spinal Simplicity LLC | 04/19/2024 | OUR |
| K240162 | LIFEPAK® 35 AC Power Adapter (41335-000001) |
Stryker Physio-Control | 04/19/2024 | MPD |
| K233737 | Ulricheasyinject Max 2M (XD 10140); Ulricheasyinject Max 3 (XD 10150); Ulricheasyinject Max 3 (XD 10180) |
ulrich GmbH & Co. KG | 04/19/2024 | IZQ |
| K232627 | HotDog Warming Mattress + Return Electrode |
Augustine Temperature Management, LLC |
04/18/2024 | DWJ |
| K240155 | Cochlear Osia System | Cochlear Americas | 04/18/2024 | PFO |
| K230233 | Prospera Spectruum Negative Pressure Wound Therapy System |
DeRoyal Industries, Inc. | 04/18/2024 | OMP |
| K233850 | Difiney Anti Snoring Device | Fissiontech LLC | 04/18/2024 | LRK |
| K240258 | Disposable Medical Face Mask (M643BE) |
Makrite Industries, Inc. | 04/18/2024 | FXX |
| K240046 | Ethylene Oxide Sterilization Supplier Change For MPO Hips |
MicroPort Orthopedics | 04/18/2024 | LPH |
| K233924 | EMBOGUARD Balloon Guide Catheter |
Neuravi Limited | 04/18/2024 | QJP |
| K232325 | RAYSCAN A-expert | Ray Co., Ltd. | 04/18/2024 | MUH |
| K234098 | Mobility Scooter (C4+) | Yongkang Yile Vehicle Co., Ltd. |
04/18/2024 | INI |
| K240085 | Zlock Lumbar Facet Fixation System |
ZygoFix Ltd. | 04/18/2024 | MRW |
| K231646 | Carilex VT¿200-i NX | Carilex Medical, Inc. | 04/17/2024 | OMP |
| K232238 | Goyo Mouthpiece S | Dimedikorea | 04/17/2024 | OBR |
| K240039 | Enteral Feeding Sets | Hangzhou Primecare Medical Co., Ltd. |
04/17/2024 | KNT |
| K240519 | Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens |
Innova Vision Inc. | 04/17/2024 | LPL |
| K240484 | MSFX Mikron Cervical Anterior Plate System |
Mikron Makina Sanayi ve Ticaret Ltd. Sti. |
04/17/2024 | KWQ |
| K240057 | TraumaGuard Intra-abdominal Pressure Sensing System |
Sentinel Medical Technologies, LLC |
04/17/2024 | EZL |
| K233186 | Uomnispace.mr | Shanghai United Imaging Healthcare Co., Ltd. |
04/17/2024 | QIH |
| K240032 | Celerity Chemical Indicator For Enspire 3000 CLCSPS |
STERIS Corporation | 04/17/2024 | JOJ |
| K233863 | TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate), TriMed ASET Foot Plating System (H-Plate), TriMed ASET Foot Plating System (Talonavicular Plate), TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate), TriMed ASET F |
TriMed, INC | 04/17/2024 | HRS |
| K233886 | Ambu® Ascope™ Duodeno 2, Ambu® Abox™ 2 |
Ambu A/S | 04/16/2024 | FDT |
| K232256 | Alcantara Thoracolumbar Plate System |
Camber Spine Technologies, LLC |
04/16/2024 | KWQ |
| K232133 | Co2 Laser System, Models: PureLase And VanLase |
CPMT Laser (Canadian Pioneer Medical Technology Corporation) |
04/16/2024 | GEX |
| K232202 | Aperio GT 450 DX | Leica Biosystems Imaging, Inc. |
04/16/2024 | PSY |
| K233962 | ReBorn (1050nm) | LightFective Ltd. | 04/16/2024 | PKT |
| K232208 | Sectra Digital Pathology Module (Version 3.3) |
Sectra AB | 04/16/2024 | PSY |
| K240748 | Nextaro® V, 20/20 | sfm medical devices GmbH | 04/16/2024 | LHI |
| K232904 | Access Ostase | Beckman Coulter | 04/15/2024 | CIN |
| K233411 | Folysil Silicone Catheter | Coloplast Corp | 04/15/2024 | EZL |
| K232926 | Novalung Ultimate Kit (US) | Fresenius Medical Care Renal Therapies Group, LLC |
04/15/2024 | QJZ |
| K240884 | Glide (91000-GL-X) | Infinite Biomedical Technology LLC |
04/15/2024 | GXY |
| K223113 | Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments |
Medentika GmbH | 04/15/2024 | NHA |
| K240773 | VisAble.IO | Techsomed | 04/15/2024 | QTZ |
| K240205 | Ez Catch Auto; Ez Catch YR; Ez Catch TR |
Veol Medical Technologies Pvt Ltd. |
04/15/2024 | GCJ |
| K232175 | XN Knee Prosthesis System | Beijing Chunlizhengda Medical Instruments Co. LTD |
04/14/2024 | JWH |
| K232164 | Access NT-proBNP | Beckman Coulter Inc. | 04/12/2024 | NBC |
| K240703 | Fine Osteotomy™ | BodyCad Laboratories, Inc. |
04/12/2024 | HRS |
| K240419 | UltraThineer Zirconia Slurry (5Y-B) |
Boston Micro Fabrication | 04/12/2024 | EIH |
| K240238 | Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 With AiCE Reconstruction Processing Unit For MR |
Canon Medical Systems Corporation |
04/12/2024 | LNH |
| K240571 | OASIS MRI System | Fujifilm Healthcare Corporation |
04/12/2024 | LNH |
| K233624 | HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx |
Hangzhou Aichek Medical Technology Co., Ltd. |
04/12/2024 | LCX |
| K240686 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card |
Healgen Scientific LLC | 04/12/2024 | NGL |
| K240418 | Stryker Orthopaedics Hip Systems Labeling Update |
Howmedica Osteonics Corp. dba Stryker Orthopaedics |
04/12/2024 | JDI |
| K232489 | VenusX | LinaTech LLC | 04/12/2024 | IYE |
| K232608 | Duo Hands-free Breast Pump | Medela LLC | 04/12/2024 | HGX |
| K240452 | Ceramic Femoral Head | MicroPort Orthopedics, Inc. |
04/12/2024 | LZO |
| K232200 | Disposable Injection Needles | Ningbo Xinwell Medical Technology Co., Ltd |
04/12/2024 | FBK |
| K233034 | Mobility+ Enteral Feeding System OTC |
Rockfield Medical | 04/12/2024 | PIF |
| K222766 | Disposable Extension Set | Shandong Ande Healthcare Apparatus Co., Ltd. |
04/12/2024 | FPA |
| K232587 | MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto Chemiluminescence Immunoassay Analyzer |
Shenzhen New Industries Biomedical Engineering Co., Ltd |
04/12/2024 | MRG |
| K232060 | TOSAMA Reusable Applicator | Tosama, d.o.o. | 04/12/2024 | HEB |
| K240109 | Medical Electronic Thermometer (FC01, FC02) |
Zhuzhou Goldenhot Medical Technology Co.,Ltd. |
04/12/2024 | FLL |
| K202531 | Azer Scientific Universal Transport Medium |
Azer Scientific, Inc. | 04/11/2024 | JSM |
| K233698 | True Enhance DL | GE Healthcare Japan Corporation |
04/11/2024 | JAK |
| K221847 | Ni2 Implant System | Newton Implant Systems, Inc |
04/11/2024 | DZE |
| K233757 | TitanPico Laser Workstation (PICO-450) |
Rhein Laser Technologies Co., Ltd. |
04/11/2024 | GEX |
| K240719 | OC JuggerKnot Soft Anchor | Riverpoint Medical | 04/11/2024 | MBI |
| K232999 | Lyric4 Hearing Aid | Sonova AG | 04/11/2024 | ESD |
| K240720 | TiLink-P SI Joint Fusion System |
SurGenTec, LLC | 04/11/2024 | OUR |
| K234057 | NIRVANA | El.En. S.p.A. | 04/10/2024 | GEX |
| K232641 | Neorad Pacs (Neorad Pacs) | Everrtech Software PVT LTD |
04/10/2024 | LLZ |
| K233313 | Keikku Electronic Stethoscope | Lapsi Health Holding B.V | 04/10/2024 | DQD |
| K232523 | Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% |
Mankind Pharma Limited | 04/10/2024 | CAF |
| K240654 | SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette |
Safecare Biotech (Hangzhou) Co., Ltd. |
04/10/2024 | NGL |
| K232409 | Electromagnetic Stimulation Systems |
Shanghai Apolo Medical Technology Co., Ltd. |
04/10/2024 | NGX |
| K240744 | Umr 680 | Shanghai United Imaging Healthcare Co., Ltd. |
04/10/2024 | LNH |
| K240089 | Face Patches (MT-12MA, MT-12MC) |
Shenzhen Kaiyan Medical Equipment Co., Ltd |
04/10/2024 | OHS |
| K240760 | CELERITY HP Indicator Tape | STERIS | 04/10/2024 | JOJ |
| K233789 | 8Q10 Surclear Smoke Plume Evacuation System |
Surnic Corporation | 04/10/2024 | FYD |
| K233561 | 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) |
Topcon Corporation | 04/10/2024 | OBO |
| K233509 | Zavation IBF System, Zavation Varisync Plate System And Varisync Spacer System, LABYRINTH System, Zavation ALIF System |
Zavation Medical Products LLC |
04/10/2024 | MAX |
| K232599 | TransForm McCarthy Mitral Annuloplasty Ring (TF) |
Genesee Biomedical Inc | 04/09/2024 | KRH |
| K233263 | Disposable Trocars | Hangzhou Kangji Medical Instrument Co., Ltd. |
04/09/2024 | GCJ |
| K232147 | CAAS Workstation | Pie Medical Imaging B.V. | 04/09/2024 | QHA |
| K233999 | GalaFLEX LITE Scaffold | Tepha, Inc. | 04/09/2024 | OOD |
| K232623 | Universal Endometrial Applicator Set (GM11009840) |
Varian Medical Systems Inc. |
04/09/2024 | JAQ |
| K231728 | BiWaze Clear System | ABMRC LLC | 04/08/2024 | NHJ |
| K240291 | EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM |
Ever Fortune.AI, Co., Ltd. |
04/08/2024 | QAS |
| K240423 | TDM Anterior Cervical Plate System |
TDM Co., Ltd. | 04/08/2024 | KWQ |
| K240021 | Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, And Tested For Use With Chemotherapy Drugs And Fentanyl Citrate |
Yue Kang Anhui Medical Products Co., Ltd |
04/08/2024 | LZA |
| K212878 | Sample Preservation Solution | Zhejiang GENE SCIENCE Co., Ltd. |
04/08/2024 | QBD |
| K234152 | ACESO Early Pregnancy Test | Aceso Laboratories, Inc. | 04/05/2024 | LCX |
| K232919 | Ambu® Ascope™ Gastro Large; Ambu® Abox™ 2 |
Ambu A/S | 04/05/2024 | FDS |
| K232823 | MCG-S (AM1000) | AMCG Co., Ltd. | 04/05/2024 | DPS |
| K233666 | CorVista System With PH Add-On | Analytics for Life, Inc. | 04/05/2024 | SAT |
| K234105 | Catalyst F1x Shoulder System | Catalyst OrthoScience, Inc. |
04/05/2024 | PHX |
| K223914 | ACTIV™ Cap | Cleansite Medical, Inc. | 04/05/2024 | QBP |
| K233192 | Wireless Smart Thermometer | Famidoc Technology Company Limited |
04/05/2024 | FLL |
| K240737 | G Surgical Marksman MIS System | G Surgical LLC | 04/05/2024 | NKB |
| K232792 | Icotec Interbody Cage System (icotec Cervical Cage, Icotec PLIF Lumbar Cage, Icotec ETurn™ TLIF Lumbar Cage) |
icotec AG | 04/05/2024 | MAX |
| K233779 | LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13) |
MacroLux Medical Technology Co., Ltd. |
04/05/2024 | EOQ |
| K233935 | DigiLine Direct Print Aligner System |
Park Dental Research Corporation |
04/05/2024 | NXC |
| K240360 | Wrinkle Treatment Device (JM2) | Shenzhen Qianyu Technology Co., Ltd. |
04/05/2024 | OHS |
| K232115 | TDM Large Bone Plate And Screw System |
TDM CO., LTD | 04/05/2024 | HRS |
| K232103 | Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) |
Terragene SA | 04/05/2024 | QKM |
| K233249 | APPRAISE-HRI | The Surgeon General, Department of the Army (TSG-DA) |
04/05/2024 | SAR |
| K240647 | Virage® Navigation System | ZimVie Spine (Zimmer Biomet Spine, Inc.) |
04/05/2024 | OLO |
| K231834 | VSP PEEK Cranial Implant | 3D Systems, Inc. | 04/04/2024 | GWO |
| K233837 | Agile Esophageal Stent System | Boston Scientific Corporation |
04/04/2024 | ESW |
| K240639 | PINNACLETM Constrained Acetabular Liners |
Depuy Ireland UC | 04/04/2024 | KWZ |
| K240172 | Preview Shoulder | Genesis Software Innovations |
04/04/2024 | QIH |
| K240361 | Power Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Power Free Pink Nitrile Examination Gloves (XS/S/M/L/XL); Power Free Purple Nitrile Examination Gloves (XS/S/M/L/XL) |
Hebei Titans Hongsen Medical Technology Co., Ltd. |
04/04/2024 | LZA |
| K232790 | KONG®-TL VBR System And KONG® C VBR System |
icotec AG | 04/04/2024 | MQP |
| K232037 | Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath |
Innovative Health, LLC. | 04/04/2024 | PNE |
| K232114 | TRIBRID® Unicompartmental Knee System |
Kyocera Medical Technologies Inc. |
04/04/2024 | HSX |
| K233026 | Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer |
Midmark Corporation | 04/04/2024 | FLE |
| K232227 | ABLATE-IQ | NeuWave Medical, Inc. | 04/04/2024 | JAK |
| K233910 | Vertex Hip Fracture Nailing System |
OrthoXel DAC | 04/04/2024 | HSB |
| K240071 | Peleton Universal Single Use Power System And Attachments |
Peleton Surgical | 04/04/2024 | SAM |
| K232027 | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument |
Sebia | 04/04/2024 | GKA |
| K240652 | Ice Cooling IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG,UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG, UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR) |
Shenzhen Ulike Smart Electronics Co.,Ltd. |
04/04/2024 | OHT |
| K233050 | ADVIA Centaur® TSH3-Ultra II (TSH3ULII) |
Siemens Healthcare Diagnostics, Inc. |
04/04/2024 | JLW |
| K240038 | Clear Moves Aligners | Space Maintainers Laboratories (SML) |
04/04/2024 | NXC |
| K240618 | Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ With Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ With Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens |
Acuity Polymers, Inc. | 04/03/2024 | HQD |
| K232653 | Blue Sky Plan Software, Blue Sky Bio Aligner Z, And Blue Sky Bio Aligner Z FLX |
Blue Sky Bio, LLC | 04/03/2024 | NXC |
| K240282 | IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521) |
Dongguan Boyuan Intelligent Technology Co.,Ltd. |
04/03/2024 | OHT |
| K240350 | AnyPlus II Spinal Fixation System |
GS Medical Co. Ltd. | 04/03/2024 | NKB |
| K240135 | Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000) |
Intuitive Surgical, Inc. | 04/03/2024 | EOQ |
| K233618 | Oxevision Sleep Device | Oxehealth Limited | 04/03/2024 | LEL |
| K233548 | Uresta® | Resilia Inc. | 04/03/2024 | HHW |
| K232899 | AI-Rad Companion Organs RT | Siemens Medical Solutions U.S.A. |
04/03/2024 | QKB |
| K230889 | Digital Thermometer | Wenzhou Yosun Medical Technology Co., Ltd. |
04/03/2024 | FLL |
| K211815 | LifeScale Gram Negative Kit (LSGN) With The LifeScale AST System |
Affinity Biosensors | 04/02/2024 | SAN |
| K232835 | Aquilion ONE (TSX-308A/3) V1.4 With PIQE Reconstruction System |
Canon Medical Systems Corporation |
04/02/2024 | JAK |
| K240888 | Calibra Abutment Resin Cement | Dentsply Sirona | 04/02/2024 | EMA |
| K233750 | ECG-less Cardiac | GE Medical Systems, LLC. | 04/02/2024 | JAK |
| K233975 | Zoom 6F Insert Catheters | Imperative Care, Inc. | 04/02/2024 | DQO |
| K240601 | SnapshotNIR Model KD205 | Kent Imaging Inc | 04/02/2024 | MUD |
| K232112 | R&G Surgical Mask | R&G Seguridad e Higiene Industrial S.A.C. |
04/02/2024 | FXX |
| K240080 | Aloe Vera Nitrile Examination Gloves (Green) Tested For Use With Chemotherapy Drugs And Fentanyl Citrate |
Syntex Healthcare Products Co., Ltd. |
04/02/2024 | LZA |
| K240635 | ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag, 12mm, ENDOCOLLECT Specimen Retrieval Bag, 15mm |
Ximedica | 04/01/2024 | GCJ |
| K233133 | Talis EMR With Talis +ACG (Talis EMR With +ACG) |
Talis Clinical, LLC | 04/01/2024 | MWI |
| K240288 | SF Push- In Anchor | Surgical Fusion Technologies GmbH |
04/01/2024 | MAI |
| K232726 | External Hex Implant System | Southern Implants (Pty) Ltd |
04/01/2024 | DZE |
| K233990 | Nitrile Disposable Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl (D5000) |
Shandong Xingyu Gloves Co., Ltd. |
04/01/2024 | LZA |
| K240043 | EVOLUTION® Hinge Knee System;GUARDIAN™ Limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/ |
MicroPort Orthopedics Inc. |
04/01/2024 | KRO |
| K240442 | MagnetOs Putty | Kuros Biosciences B.V. | 04/01/2024 | MQV |
| K233676 | Us2.v2 | Eko.ai Pte. Ltd d/b/a Us2.ai |
04/01/2024 | QIH |
| K230895 | CEFLA Dental Micromotors: I-mmr, I-mmr L, I-mmr L FLUO, I-mms, I-mms FLUO; I-xr3, I-xr3 L, I-xr3 L FLUO, I-xs4, |
CEFLA S.C. | 04/01/2024 | EBW |
| K240397 | AlphaVac MMA F1885 System (H787253020) |
AngioDynamics, Inc. | 04/01/2024 | QEZ |
| K231209 | Rejoyn | Otsuka America Pharmaceutical, Inc. |
03/30/2024 | SAP |
| K211122 | Novum IQ Large Volume Pump | Baxter Healthcare Corporation |
03/29/2024 | FRN |
| K230665 | Dose IQ Safety Software | Baxter Healthcare Corporation |
03/29/2024 | PHC |
| K233211 | AVIEW CAC | Coreline Soft Co., Ltd. | 03/29/2024 | QIH |
| K240587 | SmoothSkin Pure Unplugged (SSB3) |
CyDen Limited | 03/29/2024 | OHT |
| K233595 | Genesys Spine Sacroiliac Joint Fusion System With Navigation |
Genesys Spine | 03/29/2024 | OLO |
| K232018 | Citrated: K, KH, RTH, FFH | Haemonetics Corporation | 03/29/2024 | JPA |
| K232825 | Disposable Sphincterotome | Jiangsu Vedkang Medical Science and Technology Co., Ltd. |
03/29/2024 | KNS |
| K232031 | LUNA 3D | LAP GmbH Laser Applikationen |
03/29/2024 | IYE |
| K233068 | Disposable Surgical Gown | Nanning TECBOD Biological Technology Co.,Ltd. |
03/29/2024 | FYA |
| K240310 | LCD Monitors C310S, G310S, C316S, G316S, C616W |
Shenzhen Beacon Display Technology Co.,Ltd. |
03/29/2024 | PGY |
| K240608 | MAGNETOM Viato.Mobile | Siemens Medical Solutions USA, Inc. |
03/29/2024 | LNH |
| K233622 | AlignRT Plus | Vision RT Ltd | 03/29/2024 | IYE |
| K233409 | Eko Low Ejection Fraction Tool (ELEFT) |
Eko Health, Inc. | 03/28/2024 | QYE |
| K233909 | Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece With Maceration Wire, Cleaner™ Plus 18F Aspiration Canister |
Argon Medical Devices, Inc. |
03/28/2024 | QEW |
| K231972 | Advanta VXT Vascular Graft, Flixene Vascular Graft |
Atrium Medical Corporation |
03/28/2024 | DSY |
| K233604 | BTL-785S | BTL Industries, Inc. | 03/28/2024 | GEI |
| K233609 | CORE 500 Digital Stethoscope | Eko Health, Inc. | 03/28/2024 | DQD |
| K240171 | ProSeal™ Injector Plus (Model No. 421050) |
Epic Medical Pte. Ltd. | 03/28/2024 | ONB |
| K240567 | CustomizedBone Service | Fin-ceramica faenza s.p.a. |
03/28/2024 | GXN |
| K233669 | OEC 3D | GE OEC Medical Systems, Inc. |
03/28/2024 | OXO |
| K232013 | Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-090 |
Goodman Co., Ltd. | 03/28/2024 | PNO |
| K240295 | InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine) |
Instanosis Inc | 03/28/2024 | NGL |
| K233838 | Emprint Ablation System With Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint Ablation Generator HP (CAGENHP); Emprint Ablation Pump (CAPUMP1); Covidien™ Ablation Footswitch (RFASW); Emprint Reinforced Percutaneous Antenna 15cm (CA15L2); Emprint Reinforced |
Medtronic, Inc | 03/28/2024 | NEY |
| K240693 | LINQ II™ Insertable Cardiac Monitor (ICM) |
Medtronic, Inc. | 03/28/2024 | MXD |
| K232049 | IS-III Active Short Implant | Neobiotech Co., Ltd. | 03/28/2024 | DZE |
| K240284 | Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) |
Shenzhen Browiner Tech Co., Ltd |
03/28/2024 | IZL |
| K233719 | FDR Visionary Suite | Shimadzu Corporation | 03/28/2024 | KPR |
| K233657 | NAEOTOM Alpha | Siemens Medical Solutions USA, Inc. |
03/28/2024 | JAK |
| K232047 | VIVACE | Unimom.Co | 03/28/2024 | HGX |
| K232079 | Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested For Use With Chemotherapy Drugs And Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested For Use With Chemotherapy Drugs And Fentanyl |
WRP Asia Pacific Sdn. Bhd. |
03/28/2024 | KGO |
| K234143 | I-stat TBI Cartridge With The I-stat Alinity System |
Abbott Point of Care | 03/27/2024 | QAT |
| K222613 | ARX Liquid Amies Collection & Transport System |
ARX Sciences, Inc. | 03/27/2024 | LIO |
| K233989 | CarboClear® Posterior Cervical Screw System |
CarboFix Orthopedics Ltd. |
03/27/2024 | NKG |
| K232891 | CARPL (CARPL) | Carpl AI Inc. | 03/27/2024 | LLZ |
| K234097 | Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate |
Ever Growth (Vietnam) Corporation Limited |
03/27/2024 | LZA |
| K240045 | QStat Cartridge | HemoSonics LLC | 03/27/2024 | QFR |
| K223360 | LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing |
Huizhou Foryou Medical Devices Co., Ltd. |
03/27/2024 | FRO |
| K240389 | Secret Line Up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); I-thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150) |
HyunDae MediTech Co., Ltd. |
03/27/2024 | NEW |
| K233951 | CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, And Set Screw) |
Medtronic Sofamor Danek USA, Inc. |
03/27/2024 | NKB |
| K232253 | Modius Stress | Neurovalens Limited | 03/27/2024 | QJQ |
| K233201 | MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) |
Penumbra, Inc. | 03/27/2024 | QJP |
| K233539 | MAMMOMAT B.brilliant | Siemens Medical Solutions USA, Inc. |
03/27/2024 | MUE |
| K234150 | Lucent® XP | Spinal Elements | 03/27/2024 | MAX |
| K231425 | Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) |
Wuxi Jiajian Medical Instrument Co., Ltd |
03/27/2024 | NUH |
| K231793 | RODIN 3D Resin SPLINT, Hard/Flex |
Belport Company, Inc., Gingi-Pak |
03/26/2024 | MQC |
| K232954 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel |
BioFire Diagnostics, LLC | 03/26/2024 | QOF |
| K233069 | Removal System Large Bore 60 Cc Syringe |
Inari Medical, Inc. | 03/26/2024 | PUR |
| K231132 | J & P Click Attachments | J & P Dental Technologies |
03/26/2024 | NHA |
| K233611 | SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) |
Maine Molecular Quality Controls, Inc. |
03/26/2024 | PMN |
| K233151 | PluroGel® Antimicrobial Burn And Wound Dressing, PluroGel® Burn And Wound Dressing (OTC) |
Medline Industries, LP | 03/26/2024 | FRO |
| K240594 | Grappler Suture Anchor R3FLEX IOL System |
Paragon 28, Inc. | 03/26/2024 | MBI |
| K231984 | Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP) |
Shenzhen Hingmed Medical Instrument Co., Ltd. |
03/26/2024 | DXN |
| K233650 | SOMATOM Go.up; SOMATOM Go.now; SOMATOM Go.all; SOMATOM Go.top; SOMATOM Go.sim; SOMATOM Go.open Pro; SOMATOM X.cite; SOMATOM X.ceed |
Siemens Medical Solutions USA, Inc. |
03/26/2024 | JAK |
| K233733 | SyMRI | SyntheticMR AB (Publ) | 03/26/2024 | LNH |
| K240589 | Micropuncture Introducer Sets; Micropuncture Pedal Access Sets |
Cook Medical | 03/25/2024 | DYB |
| K234085 | LUNE™ PureHygiene | Enamel Pure | 03/25/2024 | GEX |
| K233275 | RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center For Single-use Endoscopes (CV-S1) |
Gyrus ACMI, Inc | 03/25/2024 | FGB |
| K240292 | Transcutaneous Electrical Nerve Stimulator (9029SCM) |
Hong Kong Etech Groups Limited |
03/25/2024 | NUH |
| K240620 | Cube Navigator | Medical Templates AG | 03/25/2024 | LLZ |
| K233167 | LW Implant System – Abutment | Ossvis Co., Ltd. | 03/25/2024 | NHA |
| K234080 | MEGA-IOM System With Neuro-IOM.NET Software (32/B - 32/S - 16/S) |
Soterix Medical, Inc. | 03/25/2024 | GWF |
| K233919 | VariAx 2 Distal Radius System | Stryker GmbH | 03/25/2024 | HRS |
| K231986 | Modus IR | Synaptive Medical Inc. | 03/25/2024 | IZI |
| K240329 | Electric Wheelchair (YHW001-C;YHW001-D;YHW001-E;YH W001-F) |
Yongkang Youha Electric Appliance Co.,Ltd. |
03/25/2024 | ITI |
| K232268 | STERI-OSS Implant System | Zeros Co., Ltd. | 03/25/2024 | DZE |
| K233578 | BAHADIR STERILIZATION CONTAINERS |
Bahadir USA LLC | 03/22/2024 | KCT |
| K233441 | The Vest APX System (PVAPX1) | Baxter Healthcare Corportation |
03/22/2024 | BYI |
| K232282 | Aprevo® Anterior And Lateral Lumbar Interbody Fusion Device, Aprevo® Transforaminal Lumbar Interbody Fusion Device |
Carlsmed, Inc. | 03/22/2024 | MAX |
| K240715 | Idys® C ZP 3DTi | Clariance | 03/22/2024 | OVE |
| K231953 | Biatain Fiber Ag (33570 - 5 Cm X 5 Cm / 2 In X 2 In); Biatain Fiber Ag (33572 - 10 Cm X 12 Cm / 4 In X 5 In); Biatain Fiber Ag (33574 - 15 Cm X 15 Cm / 6 In X 6 In); Biatain Fiber Ag (33576 - 2.5 Cm X 46 Cm / 1 In X 18 In); Biatain Fiber Ag (33578 - 20 Cm X 30 Cm / 8 In X 12 In) |
Coloplast Corp. | 03/22/2024 | FRO |
| K232548 | Corsano CardioWatch 287-2 System |
Corsano Health B.V. | 03/22/2024 | MSX |
| K233262 | Dukal SMS Sterilization Wrap | Dukal LLC | 03/22/2024 | FRG |
| K233148 | Augment Off-Axis Instrument System |
Fix Surgical | 03/22/2024 | PHX |
| K231930 | Digital Ultrasonic Diagnostic Imaging System (Model: F6) |
GuangDong Youkey Medical Co., Ltd. |
03/22/2024 | IYN |
| K232067 | Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector |
Medivators (A Subsidiary of STERIS Corporation) |
03/22/2024 | ODC |
| K232354 | Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software |
Murata Vios, Inc. | 03/22/2024 | DRT |
| K231926 | NeuroStar Advanced Therapy System (All Previously Cleared Models) |
Neuronetics, Inc. | 03/22/2024 | OBP |
| K240690 | STRUXXURE® MCS Anterior Cervical Plate System |
Nexxt Spine | 03/22/2024 | KWQ |
| K231938 | Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate And Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested For Use With Chemotherapy Drugs, Fentanyl Citrat |
O&M Halyard, Inc. | 03/22/2024 | LZA |
| K232169 | FITBONE® Transport And Lengthening System |
Orthofix Srl | 03/22/2024 | HSB |
| K231806 | Thermo Scientific Oxoid Rezafungin Disc (5 Μg) RZF5 |
Oxoid Limited (Part of Thermo Fisher Scientific) |
03/22/2024 | JTN |
| K231795 | QuickVue COVID-19 Test | Quidel Corporation | 03/22/2024 | QYT |
| K231927 | Elecsys PTH , Elecsys PTH STAT | Roche Diagnostics | 03/22/2024 | CEW |
| K240540 | Umr Omega | Shanghai United Imaging Healthcare Co., Ltd. |
03/22/2024 | LNH |
| K240225 | Shockwave Intravascular Lithotripsy (IVL) System With The Shockwave E8 Peripheral IVL Catheter |
Shockwave Medical, Inc. | 03/22/2024 | PPN |
| K232322 | MAGNETOM Terra; MAGNETOM Terra.X |
Siemens Medical Solutions USA, Inc. |
03/22/2024 | LNH |
| K232431 | Syngo.ct Brain Hemorrhage | Siemens Medical Solutions USA, Inc. |
03/22/2024 | QAS |
| K233569 | SeptAlign | Spirair, Inc. | 03/22/2024 | NHB |
| K240522 | Esophageal TTS Stent | Taewoong Medical | 03/22/2024 | ESW |
| K233713 | Pilling Tracheostomy Tubes | Teleflex Medical | 03/22/2024 | BTO |
| K232920 | RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr X 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr X 26cm |
Ureteral Stent Company | 03/22/2024 | FAD |
| K230088 | Ankle Truss System (ATS) | 4WEB Medical, Inc. | 03/21/2024 | SAI |
| K240253 | Reach Needle | Aerin Medical Inc. | 03/21/2024 | BSP |
| K234006 | AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test |
AllSource Screening Solutions |
03/21/2024 | NGL |
| K233980 | ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System |
DePuy Ireland UC | 03/21/2024 | KRO |
| K233665 | DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System |
DePuy Synthes | 03/21/2024 | HRS |
| K232439 | Electrical Stimulator System | Gymmax Technology Shenzen Co., Ltd. |
03/21/2024 | NUH |
| K232568 | IPG Medical Family Of Thulium Fiber Lasers, Surgical Fibers, And Accessories |
IPG Medical Corporation | 03/21/2024 | GEX |
| K234062 | APTUS Hand Scaphoid Plates | Medartis AG | 03/21/2024 | HRS |
| K240530 | DynaNail Mini Tapered Hybrid | MedShape, Inc. | 03/21/2024 | HWC |
| K240754 | N2 | MegaGen Implant Co., Ltd. |
03/21/2024 | EIA |
| K233926 | Accufit | Mettler Electronics Corporation |
03/21/2024 | IPF |
| K240122 | Normatec Elite | NormaTec Industries, LP | 03/21/2024 | IRP |
| K234081 | RedDrop ONE (One) | RedDrop Dx | 03/21/2024 | FMK |
| K233753 | AI-Rad Companion (Pulmonary) | Siemens Healthcare GmbH | 03/21/2024 | JAK |
| K240309 | Tandem Mobi Insulin Pump With Interoperable Technology |
Tandem Diabetes Care, Inc. |
03/21/2024 | QFG |
| K240179 | Medical Diode Laser (Model: L2) |
Wuhan Pioon Technology Co., Ltd. |
03/21/2024 | GEX |
| K234052 | Access Ferritin | Beckman Coulter, Inc | 03/20/2024 | JMG |
| K234047 | Automatic Registration | Brainlab AG | 03/20/2024 | OLO |
| K240537 | SMARTXIDE PRO | El.En. S.p.A. | 03/20/2024 | GEX |
| K233002 | BEED 2,5, BEED 3,8 | Excelsior Resources LLC | 03/20/2024 | GEI |
| K234130 | Portrait™ Mobile Monitoring Solution Consists Of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™ Core Services (Portrait CSSXB) • Portrait™ Clinical Alarming Unit (Portrait CAU01) • Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB) • Portrait™ Mobile Patient Monit |
GE Medical Systems Information Technologies, Inc. |
03/20/2024 | MWI |
| K233642 | InMode RF System | InMode Ltd. | 03/20/2024 | GEI |
| K234049 | Straumann® BLC And TLC Implants - Line Extension |
Institut Straumann AG | 03/20/2024 | DZE |
| K232654 | Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs And Fentanyl) |
Nephron Nitrile, LLC. | 03/20/2024 | LZA |
| K233375 | Tranquil-L Interbody System | Nexus Spine, LLC | 03/20/2024 | MAX |
| K240507 | NuVasive AttraX Scaffold | NuVasive, Inc. | 03/20/2024 | MQV |
| K231974 | PATHFAST®hs-cTnI-II | PHC Corporation | 03/20/2024 | MMI |
| K240574 | BruxZir® Radiant | Prismatik Dentalcraft, Inc. |
03/20/2024 | EIH |
| K233901 | Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009) |
Shenzhen Desida Technology Co., Ltd. |
03/20/2024 | BTA |
| K234090 | EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) |
SurgVision GmbH | 03/20/2024 | IZI |
| K240743 | Peak Universal Bond | Ultradent Products, Inc. | 03/20/2024 | KLE |
| K232125 | V-PVP | VITROMED GmbH | 03/20/2024 | MQL |
| K240165 | Aneroid Sphygmomanometer With Stethoscope; Aneroid Sphygmomanometer |
Wenzhou Longwan Medical Device Factory |
03/20/2024 | DXQ |
| K234024 | HWJECT Auto-disable Syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd |
03/19/2024 | FMF |
| K231843 | ARX Viral Transport Media Collection And Transport System |
ARX Sciences, Inc. | 03/19/2024 | JSM |
| K231719 | Medical Surgical Mask | Azur Medical Company Inc. |
03/19/2024 | FXX |
| K232682 | Pre-Sintered Zirconia Coloring Liquid |
Chengdu Besmile Medical Technology Co., Ltd. |
03/19/2024 | EIH |
| K233772 | Disposable Dual Action Tissue Closure Device |
Mirco-Tech (Nanjing) Co., Ltd. |
03/19/2024 | PKL |
| K232619 | MATRIX HA PEEK Cervical IBF System |
Sapphire Medical Group | 03/19/2024 | ODP |
| K240668 | Amydi-med Disposable Non-invasive EEG Electrodes |
Shenzhen Amydi-med Electrics Tech Co., Ltd. |
03/19/2024 | GXY |
| K233146 | Blood Pressure Monitor | Shenzhen Jamr Technology Co., Ltd. |
03/19/2024 | DXN |
| K240139 | Real Intelligence™ CORI™ | Blue Belt Technologies, Inc. |
03/18/2024 | OLO |
| K233660 | Ncommand Lite System | Ionic Health | 03/18/2024 | LLZ |
| K233599 | X-Clever (ASHK100G) | LG Electronics Inc. | 03/18/2024 | LLZ |
| K240113 | CORIOGRAPH Knee Pre-Op Plan | Smith & Nephew, Inc | 03/18/2024 | PBF |
| K240515 | Union® MAX Cervical Plate System |
Ulrich Medical USA, Inc. | 03/18/2024 | KWQ |
| K230981 | Meriglu Topical Skin Adhesive | M/s Meril Endo Surgery Private Limited |
03/16/2024 | MPN |
| K233814 | 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M) |
3M Company | 03/15/2024 | FRC |
| K234115 | APRO 55 Catheter | Alembic, LLC | 03/15/2024 | DQY |
| K233342 | CINA-ASPECTS | Avicenna.AI | 03/15/2024 | POK |
| K233986 | BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 Μg/ml) |
Becton, Dickinson and Company |
03/15/2024 | LON |
| K233307 | Intensity Pulsed Light Therapy System |
Beijing ADSS Development Co., Ltd. |
03/15/2024 | ONF |
| K233747 | Concha Sol Hearing Aids (CL-1001) |
Concha Labs | 03/15/2024 | QUH |
| K240441 | MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw |
DePuy Mitek | 03/15/2024 | MAI |
| K232327 | Endorail | Endostart s.r.l. | 03/15/2024 | ODC |
| K240117 | Aventus Thrombectomy System (IM-2001/IM-0002) |
Inquis Medical | 03/15/2024 | QEW |
| K233881 | Ivwatch® Model 400 | ivWatch, LLC | 03/15/2024 | PMS |
| K231856 | TopFine® LDS (Low Dead Space) Syringe (2 Models (TS-LDS2334, TS-LDS2534)) |
MedExel Co., Ltd. | 03/15/2024 | QNQ |
| K240466 | STARband 3D | Orthomerica Products Inc. |
03/15/2024 | OAN |
