510(k) Clearances in 2024 — Page 7

3,129 510(k) clearances total

Browse FDA 510(k) clearances granted in 2024. RegDataLab tracks 3,129 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2024 (page 7 of 63)
510(k) clearancesDetails
K243409 — KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)Karl Storz SE & CO. KG Nov 27, 2024
K243362 — SmoothSkin Pure Switch (SSC1)Cyden Limited Nov 27, 2024
K242638 — LED Light Therapy Machine (G1, G3, G4, G6)Shenzhen Walton Technology Co., Ltd. Nov 27, 2024
K242187 — BioBrace®Conmed Corporation Nov 27, 2024
K242444 — HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. Nov 27, 2024
K243354 — Remunity SystemDeka Research & Development Corp. Nov 27, 2024
K243221 — RadiForce RX570; RadiForce RX570-AREizo Corporation Nov 27, 2024
K241115 — SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous CatheterSpectrum Vascular Nov 27, 2024
K243355 — Ceragem Automatic Thermal Massager (CGM-MB-1902)Ceragem Co., Ltd. Nov 27, 2024
K240994 — NexpowderNextbiomedical Co., Ltd. Nov 27, 2024
K233273 — C&B Ceramic; C&B Permanent; C&B InterimPrevest Denpro Limited Nov 27, 2024
K243408 — TACTIX Vector Syndesmosis SystemVilex, LLC Nov 27, 2024
K242796 — CryoGlow (FW3XXXX)Sharkninja Operating, LLC Nov 27, 2024
K241353 — PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle SetBard Access Systems, Inc. Nov 27, 2024
K240645 — Sonix HealthOntact Health Co., Ltd. Nov 27, 2024
K241899 — Pelvic Floor Stimulator (Intrelief PFE)Easymed Instruments Co., Ltd. Nov 27, 2024
K241835 — AirSculpt Body Contouring System (AIRS-1-SYS)Cellmyx Nov 27, 2024
K242308 — Power wheelchairZhejiang Zhonglei Medical Technology Co. , Ltd. Nov 27, 2024
K243193 — Cross Wise™ Multi-Use RF Adapter CableCirca Scientific, Inc. Nov 26, 2024
K242494 — OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC Nov 26, 2024
K242657 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mLThermo Fisher Scientific Nov 26, 2024
K243191 — Atlas Spine Lateral Expandable Interbody SystemAtlas Spine, Inc. Nov 26, 2024
K240650 — LungProtectTraferox Technologies, Inc. Nov 26, 2024
K241995 — HyperFlex™ Bunion Correction SystemFootbridge Medical Nov 26, 2024
K242810 — RadUnity (Version 1.0.0)Radunity Corp. Nov 26, 2024
K242559 — Digital TempSprintray, Inc. Nov 26, 2024
K241390 — NeuroMatchLVIS Corporation Nov 26, 2024
K243050 — TriMed Posterior Malleolus Fixation SystemTriMed, Inc. Nov 26, 2024
K242258 — MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)Asg Superconductors S.P.A. Nov 26, 2024
K231655 — 4CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd. Nov 26, 2024
K243118 — Arm Blood Pressure Monitor (model: BPM-A7VL)Shenzhen Imdk Medical Technology Co., Ltd. Nov 26, 2024
K242049 — SureCath SetColoplast Corp. Nov 26, 2024
K240818 — R2P Radifocus Glidewire AdvantageTerumo Corporation Nov 26, 2024
K240897 — CellinewVIOL Co., Ltd. Nov 26, 2024
K231859 — PrimmaArtDentscare Ltda Nov 26, 2024
K242631 — REGENETEN™ Bioinductive ImplantSmith & Nephew Inc., Endoscopy Div. Nov 26, 2024
K242961 — Intraluminal Applicator SetVarian Medical Systems Nov 26, 2024
K242318 — da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc. Nov 26, 2024
K242245 — Customized AbutmentArum Dentistry Co., Ltd. Nov 25, 2024
K241851 — Versus™ Catheter (VS110-8B)Liquet Medical, Inc. Nov 25, 2024
K232588 — Aluna 2Knox Medical Diagnostics Nov 25, 2024
K232982 — EMS Sculpt MachineShandong Huamei Technology Co., Ltd. Nov 25, 2024
K240575 — WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)Eemagine Medical Imaging Solutions GmbH Nov 25, 2024
K241692 — MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc. Nov 25, 2024
K241588 — Electric Wheelchair (KR8803)Zhejiang Kairui Medical Device Co., Ltd. Nov 25, 2024
K241831 — Transpara (2.1.0)Screenpoint Medical B.V. Nov 25, 2024
K243345 — Aptima BV Assay; Aptima CV/TV AssayHologic, Inc. Nov 25, 2024
K242253 — JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie Nov 25, 2024
K242538 — 3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M3M Company Nov 25, 2024
K243162 — World LinerSignature Orthopaedics Pty, Ltd. Nov 25, 2024
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