510(k) Clearances

174,759 clearances total

K231343 — Redemption Duo Hindfoot Nail SystemVilex, LLC Tue Jan 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231910 — DermRays ReviveWuhan Lotuxs Technology Co., Ltd. Tue Jan 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240020 — Ziehm Vision FDZiehm Imaging GmbH Tue Jan 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232942 — G-Vitri™ Vitrification Freeze Media; G-Vitri™ Vitrification Thawing MediaGimbo Medical Technology Shenzhen Co., Ltd. Tue Jan 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K230794 — Rebuilder Nerve Guidance ConduitCelestray Biotech Company, LLC., Mon Jan 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233394 — Gem Flow Now (GEM2770-FN)Synovis Micro Companies Alliance Sun Jan 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233224 — Epilaser ProEpilady 2000, LLC Sat Jan 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233598 — Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other DrugsAnhui Intco Medical Products Co., Ltd. Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234116 — Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234145 — ViSiGi 3D Gastric Sizing TubeBoehringer Laboratories Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232864 — EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream IINantong Egens Biotechnology Co., Ltd. Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231785 — Perifit PumpX6 Innovations Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231715 — MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233485 — M-WaveZynex Medical, Inc. Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231282 — LifeOutcomes C-Quest™ Blood Culture Sampling DeviceLifeoutcomes, LLC Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233299 — ExactechGPS® SystemBlue Ortho Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234118 — CentriMag™ Acute Circulatory Support SystemABBOTT MEDICAL Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231329 — Aptima Neisseria gonorrhoeae AssayHologic, Inc. Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231303 — Arm-type Fully Automatic Digital Blood Pressure MonitorJoytech Healthcare Co. , Ltd. Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232182 — One-FilMediclus Co., Ltd. Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233508 — iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234109 — Ziehm Solo FDZiehm Imaging GmbH Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232450 — Disposable Hemostatic ClipsZhejiang Soudon Medical Technology Co., Ltd. Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233735 — ADIRA™ Lateral Plate SystemGlobus Medical, Inc. Thu Jan 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234127 — Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV BlockerCooperVision, Inc. Thu Jan 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233425 — FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)Sutter Medizintechnik GmbH Thu Jan 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233893 — AlphaVent Knotless SP PEEK AnchorStryker Endoscopy Thu Jan 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233714 — BreViewGE Medical Systems SCS Thu Jan 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232665 — GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)Convatec Thu Jan 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232417 — MR Q; MR Q SUPINE; MR Q SLTMeridian AG Thu Jan 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232912 — Facet Aurora Reusable Lancet BaseFacet Technologies, LLC Thu Jan 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231290 — Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitThe Binding Site, Ltd. Wed Jan 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233195 — Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation Wed Jan 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231607 — Axial3D Cloud Segmentation ServiceAxial Medical Printing Limited Wed Jan 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233208 — NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw TitaniumNobel Biocare AB Wed Jan 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232676 — Dental Porcelain PowderChengdu Besmile Medical Technology Co., Ltd. Tue Jan 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231305 — Endoform Dental MembraneAroa Biosurgery , Ltd. Tue Jan 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K230836 — SchurSign Tissue MarkerSurgmark GmbH Tue Jan 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232917 — Chemo MouthpieceChemo Mouthpiece, LLC Tue Jan 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231187 — Nano-Check™ COVID-19 Antigen TestNano-Ditech Corporation Tue Jan 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233013 — 2-Way 100% Silicone Cleartract CatheterSilq Technologies Corporation Tue Jan 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232673 — Dental Glass CeramicsChengdu Besmile Medical Technology Co., Ltd. Tue Jan 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231299 — Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connectorCair Lgl Mon Jan 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231423 — Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)Shenzhen Roundwhale Technology Co. , Ltd. Mon Jan 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K230841 — NailLiftJps Corporation Mon Jan 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233450 — MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown ScrewMegagen Implant Co., Ltd. Mon Jan 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233887 — IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD, UI08 BR, UI08 DB, UI08 BL, UI08 GP, UI08 PN, UI08 RE, UI08 WH, UI08 PW, UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20 GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW)Shenzhen Ulike Smart Electronics Co., Ltd. Mon Jan 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234087 — restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D Mon Jan 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233105 — RESPONSE™ Rib and Pelvic SystemOrthoPediatrics Corp. Sat Jan 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232679 — Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration CanisterArgon Medical Devices, Inc. Fri Jan 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
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