510(k) Clearances

174,759 clearances total

K232741 — SmartAdjust(TM) technologyInsulet Corporation Wed May 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233481 — AltiVate Reverse® GlenoidEncore Medical L.P. Wed May 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233655 — Lingo Glucose SystemAbbott Wed May 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233389 — EK Digital AbutmentsHiossen, Inc. Wed May 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233166 — NET Recovery Corp/NET DeviceNet Recovery Wed May 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240049 — LINK(TM) External FixatorMetric Medical Devices, Inc. Wed May 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240159 — InnoVoyce VYLOInnovoyce Wed May 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241190 — PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile SyringePoonglim Pharmatech, Inc. Wed May 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232672 — EasyScreen Gastrointestinal Parasite Detection KitGenetic Signatures Limited Wed May 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241207 — SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02)Devoro Medical, Inc. Wed May 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240784 — Temperature Sensor Probe (ABL-18TP20)Varian Medical Systems, Inc. Wed May 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240629 — Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and FentanylXingyu Medical Tech Co., Ltd. Tue May 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241177 — React 71 CatheterMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular Tue May 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K223629 — SpiroSphere, SpiroSphereECG, CardioSphereEresearchtechnology GmbH Tue May 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233076 — Laser Speckle Imaging System (RFLSI CZW)Rwd Life Science Co., Ltd. Tue May 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240305 — ANNE LimbSibel Health, Inc. Tue May 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240874 — Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)Theralaser Medtech (China) Co., Ltd. Tue May 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240304 — Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)Enpuno Biotechnology Co., Ltd. Tue May 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233344 — Regenalase Laser SystemIpg Medical Tue May 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240410 — EVOLVE Nitric Oxide Delivery SystemMalinckrodt Manufacturing, LLC Tue May 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240749 — PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc. Tue May 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240592 — Wolff's Law Anterior Cervical Plate SystemSpinal Simplicity, LLC Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231426 — 8plant Implant SystemHoowon Edi Co., Ltd. Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233777 — PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)Primed Medical Products, Inc. Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233285 — KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc. Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240864 — PacePro WireOpsens, Inc. Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K231939 — Renasys EdgeSmith & Nephew Medical, Ltd. Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233089 — NeoSpan® Compression Implant SystemIn2bones USA, LLC Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233386 — Monik™ - Disposable Endoscopic TrocarM/s. Meril Endo Surgery Private Limited. Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240810 — Anti Grinding GuardXiamen Yizhou Imp. & Exp. Co., Ltd. Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240769 — LVivo IQSDia Imaging Analysis, Ltd. Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232788 — INSPIRA ART100Inspira Technologies Oxy B.H.N. , Ltd. Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232632 — Racz Neurostat RF GeneratorEpimed International Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234154 — uPMR 790Shanghai United Imaging Healthcare Co., Ltd. Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240723 — da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)Intuitive Surgical Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233111 — ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTCFoshan United Medical Technologies, Ltd. Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241178 — DEKA ACE Pump SystemDeka Research and Development Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232639 — Apollo TMS Therapy SystemMag & More GmbH Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240827 — SET-5002Shimadzu Corporation Medical Systems Division Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232646 — Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)Cook Biotech Incorporated Fri May 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233251 — NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc. Thu May 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233868 — dima Print Teeth & TempKulzer, LLC Thu May 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240701 — Drill Guide; Drill Bit; Spine & Trauma NavigationBrainlab AG Thu May 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233108 — VinDr-MammoVinbigdata Joint Stock Company Thu May 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232603 — CamAPS FXCamdiab , Ltd. Thu May 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240294 — Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH Thu May 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241396 — uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc. Thu May 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233120 — CWM-930S, FIXER DV9Chungwoo Co., Ltd. Thu May 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232642 — AirKEE T900Healkee Medical Pte, Ltd. Thu May 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232602 — 3DMatrix Surgical MeshPrintbio, Inc. Thu May 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
← Previous Page 123 of 3496 Next →