510(k) Clearances — Page 130

176,223 clearances total

Browse all FDA 510(k) medical device clearances. RegDataLab tracks 176,223 clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances (page 130 of 3,525)
ClearancesDetails
K242746 — OvertureTi Knee Resurfacing SystemTMOverture Orthopaedics Oct 7, 2024
K242693 — DEKA Infusion System, DEKA Administration SetDeka Research And Development Corporation Oct 7, 2024
K242375 — OR3O Dual Mobility SystemSmith & Nephew, Inc. Oct 7, 2024
K240485 — LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)Huizhou Foryou Medical Devices Co., Ltd. Oct 7, 2024
K241029 — SpineUs™ SystemVerdure Imaging Oct 7, 2024
K242357 — Water Container (MAJ-901); Water Container (MAJ-902)Olympus Medical Systems Corporation Oct 7, 2024
K242445 — Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating SystemStryker GmbH Oct 6, 2024
K242721 — Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131)Shenzhen Finicare Co., Ltd. Oct 4, 2024
K242679 — Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series)Fengh Medical Co., Ltd. Oct 4, 2024
K241434 — Video Ureteroscope SystemHunan Vathin Medical Instrument Co., Ltd. Oct 4, 2024
K242106 — AuST Steerable SheathCenterPoint Systems, LLC Oct 4, 2024
K241052 — Bladeless Trocar; Bladed Trocar; Hasson TrocarAdvamedix, GmbH Oct 4, 2024
K241746 — UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE; UMED REPROCESSED AIRCAST ELITE CALF CUFF 3040 3050; UMED REPROCESSED CTC VP 501 CALF CUFF; UMED REPROCESSED CTC VP 520 FOOT CUFFUnited Medical Resources, LLC Oct 4, 2024
K241854 — Power WheelchairAnhui Jbh Medical Apparatus Co., Ltd. Oct 4, 2024
K242343 — BPS Wrist Fracture SystemOrthonovis, Inc. Oct 4, 2024
K241298 — QUADSENSEEventum Orthopaedics, Ltd. Oct 4, 2024
K240553 — LVivo Software ApplicationDia Imaging Analysis, Ltd. Oct 4, 2024
K240376 — Electroporation System (N3000)Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Oct 4, 2024
K242351 — Zeta Cranial Navigation System (ZNS131-US)Zeta Surgical, Inc. Oct 4, 2024
K241869 — BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart ReaderVivachek Biotech (Hangzhou) Co., Ltd. Oct 4, 2024
K241796 — TroCare TroKit Laparoscope Lens Wiper (CP000626)TroCare, LLC Oct 4, 2024
K242325 — GripTract-GI Endoscopic Tissue Manipulator Lower GI ModelsActuated Medical, Inc. Oct 4, 2024
K240675 — Endoscopic Injection NeedlesPromisemed Hangzhou Meditech Co., Ltd. Oct 4, 2024
K242364 — IdentiTi™ II Interbody SystemAlphatec Spine, Inc. Oct 4, 2024
K242671 — Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc. Oct 4, 2024
K242652 — Lunit INSIGHT DBT v1.1Lunit, Inc. Oct 4, 2024
K241245 — EchoSolv ASEcho IQ, Ltd. Oct 4, 2024
K240074 — Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2)Shenzhen Besdata Technology Co., Ltd. Oct 4, 2024
K241472 — Icona Hip StemCorin U.S.A. Limited Oct 3, 2024
K233497 — Rest Assure SystemSomnomed, Inc. Oct 3, 2024
K240393 — Exactech® TRULIANT® Knee SystemExactech, Inc. Oct 3, 2024
K242660 — Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration SetsZevex, Inc. Oct 3, 2024
K242507 — OBSIDIO™ Conformable EmbolicBoston Scientific Oct 3, 2024
K241977 — Injectable Root Canal Bioceramic Sealer (i-MTA SP)Longly Biotechnology (Wuhan) Co., Ltd. Oct 3, 2024
K240808 — Pulse Oximeter (WS20A)Hunan Accurate Bio-Medical Technology Co., Ltd. Oct 3, 2024
K240586 — Additive Manufacturing Zirconia Customized RestorationHangzhou Thales Medtech Co., Ltd. Oct 3, 2024
K242616 — Lantern® HipOrthalign, Inc. Oct 3, 2024
K241487 — Interwedge® Standalone LateralFoundation Surgical Group, Inc. Oct 2, 2024
K241907 — Anovo Surgical System (model 6N)Momentis Surgical , Ltd. Oct 2, 2024
K241925 — VitruvianScan (v1.0)Perspectum, Ltd. Oct 2, 2024
K242302 — RejuvaKnee™ Collagen Meniscus ImplantCollagen Matrix, Inc. Oct 2, 2024
K240889 — ARTFX Lumbar PEEK CagesArtfx Medical Oct 2, 2024
K241097 — Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc. Oct 2, 2024
K242005 — Versana Premier; Versana Premier Lotus; LOGIQ FGE Medical Systems Ultrasound And Primary Care Diagnostics Oct 2, 2024
K241561 — MammoScreen BDTherapixel Oct 2, 2024
K242377 — REMEDY Stemmed Knee Spacer System with All-Poly Tibial ComponentOsteoremedies, LLC Oct 2, 2024
K240529 — 8F Modified Sheath SystemRoute 92 Medical, Inc. Oct 2, 2024
K242613 — NxTAG® Respiratory Pathogen PanelLuminex Molecular Diagnostics, Inc. Oct 2, 2024
K240153 — Ceramic Etchant (HF-5 and HF-9)Liaoning Upcera Co., Ltd. Oct 2, 2024
K242678 — Definium Pace Select ETGe Hualun Medical Systems Co. , Ltd. Oct 1, 2024
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