510(k) Clearances

174,759 clearances total

K242184 — Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);Alcon Laboratories, Inc. Wed Dec 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243265 — Ion 3DSurGenTec, LLC Wed Dec 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241197 — DeepRhythmAIMedicalgorithmics S.A. Wed Dec 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242685 — Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc. Wed Dec 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243475 — Chemical Indicator for enspire CLCSPS (LCC015)STERIS Corporation Wed Dec 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242185 — Rextar ProRaypia Co., Ltd. Wed Dec 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242643 — CapsoCam Plus (SV-3) Capsule Endoscopy SystemCapsoVision, Inc. Wed Dec 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240671 — XBeam (v2)Xstrahl, Ltd. Wed Dec 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242188 — ClearRead CT CACRiverain Technologies, Inc. Tue Dec 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243467 — Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)Osteonic Co., Ltd. Tue Dec 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241486 — Sofsilk™ Coated Braided Silk SutureCovidien Tue Dec 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242861 — TrueLok ElevateOrthofix Srl Tue Dec 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243470 — Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd. Tue Dec 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243454 — Verruca-Freeze HCryosurgery, Inc. Tue Dec 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243418 — Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate TubingMicro Therapeutics, Inc. d/b/a ev3 Neurovascular Mon Dec 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243020 — MIDASVuIntravu, Inc. Mon Dec 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240475 — Hintermann Series H2 Total Ankle SystemVilex, LLC Mon Dec 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242619 — GroWell BT Hair Growth System (GW10042)Apira Science, Inc. Mon Dec 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243232 — GripMateSynthon Hispania S.L. Mon Dec 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241871 — Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. Mon Dec 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243433 — enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemSTERIS Corporation Mon Dec 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K223120 — Ventoux VC2; Ventoux VC3Flight Medical Innovations , Ltd. Mon Dec 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243375 — Ruthless Spine RJBRuthless, LLC Dba Ruthless Spine Fri Nov 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242225 — Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic CatheterSurgical Instrument Service and Savings, Inc. Fri Nov 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241628 — YO Home Sperm TestMedical Electronic Systems , Ltd. Fri Nov 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241090 — Evie Med RingMovano Inc. Dba Movano Health Fri Nov 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243221 — RadiForce RX570; RadiForce RX570-AREizo Corporation Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243355 — Ceragem Automatic Thermal Massager (CGM-MB-1902)Ceragem Co., Ltd. Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242444 — HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241115 — SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous CatheterSpectrum Vascular Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242638 — LED Light Therapy Machine (G1, G3, G4, G6)Shenzhen Walton Technology Co., Ltd. Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243354 — Remunity SystemDeka Research & Development Corp. Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240994 — NexpowderNextbiomedical Co., Ltd. Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242187 — BioBrace®Conmed Corporation Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K233273 — C&B Ceramic; C&B Permanent; C&B InterimPrevest Denpro Limited Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243408 — TACTIX Vector Syndesmosis SystemVilex, LLC Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242796 — CryoGlow (FW3XXXX)Sharkninja Operating, LLC Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241353 — PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle SetBard Access Systems, Inc. Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240645 — Sonix HealthOntact Health Co., Ltd. Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243362 — SmoothSkin Pure Switch (SSC1)Cyden Limited Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241899 — Pelvic Floor Stimulator (Intrelief PFE)Easymed Instruments Co., Ltd. Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243409 — KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)Karl Storz SE & CO. KG Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241835 — AirSculpt Body Contouring System (AIRS-1-SYS)Cellmyx Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242308 — Power wheelchairZhejiang Zhonglei Medical Technology Co. , Ltd. Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243193 — Cross Wise™ Multi-Use RF Adapter CableCirca Scientific, Inc. Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242494 — OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243191 — Atlas Spine Lateral Expandable Interbody SystemAtlas Spine, Inc. Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241995 — HyperFlex™ Bunion Correction SystemFootbridge Medical Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242810 — RadUnity (Version 1.0.0)Radunity Corp. Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240650 — LungProtectTraferox Technologies, Inc. Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
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