510(k) Clearances — Page 105
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K240645 — Sonix Health | Ontact Health Co., Ltd. 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) |
| K241835 — AirSculpt Body Contouring System (AIRS-1-SYS) | Cellmyx Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242308 — Power wheelchair | Zhejiang Zhonglei Medical Technology Co. , Ltd. Wed Nov 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242494 — OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct | Riverpoint Medical, LLC Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242657 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL | Thermo Fisher Scientific Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240650 — LungProtect | Traferox Technologies, Inc. Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243191 — Atlas Spine Lateral Expandable Interbody System | Atlas Spine, Inc. Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241995 — HyperFlex Bunion Correction System | Footbridge 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) |
| K243193 — Cross Wise Multi-Use RF Adapter Cable | Circa Scientific, Inc. Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242559 — Digital Temp | Sprintray, Inc. Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241390 — NeuroMatch | LVIS Corporation Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243050 — TriMed Posterior Malleolus Fixation System | TriMed, Inc. Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242258 — MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) | Asg Superconductors S.P.A. Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231655 — 4CIS® Chiron Spinal Fixation System | Solco Biomedical Co., Ltd. Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243118 — Arm Blood Pressure Monitor (model: BPM-A7VL) | Shenzhen Imdk Medical Technology Co., Ltd. Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242049 — SureCath Set | Coloplast Corp. Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240818 — R2P Radifocus Glidewire Advantage | Terumo Corporation Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240897 — Cellinew | VIOL Co., Ltd. Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231859 — PrimmaArt | Dentscare Ltda Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242631 — REGENETEN Bioinductive Implant | Smith & Nephew Inc., Endoscopy Div. Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242961 — Intraluminal Applicator Set | Varian Medical Systems Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242318 — da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242245 — Customized Abutment | Arum Dentistry Co., Ltd. Mon Nov 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232588 — Aluna 2 | Knox Medical Diagnostics Mon Nov 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241851 — Versus Catheter (VS110-8B) | Liquet Medical, Inc. Mon Nov 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232982 — EMS Sculpt Machine | Shandong Huamei Technology Co., Ltd. Mon Nov 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241692 — MIS LYNX Conical Connection Implant System | Dentsply Sirona, Inc. Mon Nov 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243345 — Aptima BV Assay; Aptima CV/TV Assay | Hologic, Inc. Mon Nov 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241588 — Electric Wheelchair (KR8803) | Zhejiang Kairui Medical Device Co., Ltd. Mon Nov 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240575 — WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) | Eemagine Medical Imaging Solutions GmbH Mon Nov 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241831 — Transpara (2.1.0) | Screenpoint Medical B.V. Mon Nov 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242253 — JARVIS Glenoid Reverse Shoulder Prosthesis | FH Industrie Mon Nov 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| 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 490M | 3M Company Mon Nov 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243162 — World Liner | Signature Orthopaedics Pty, Ltd. Mon Nov 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242971 — AccurSound Electronic Stethoscope (AS101) | Heroic Faith International , Ltd. Mon Nov 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243334 — Nooro Body & Foot Stimulator (SM9141, SM9142) | Xf Agencija Limited Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242259 — Cala kIQ | Cala Health, Inc. Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241953 — SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology | PAJUNK GmbH Medizintechnologie Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242968 — Giftlife® Single-Step Medium Plus | Gimbo Medical Technology Shenzhen Co., Ltd. Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233567 — OsteoCoil Nitinol Compression System (Multiple Component PNs) | Flower Orthopedics Corporation Dba Conventus Flower Ortho Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241529 — Powered Wheelchair (NXN20-209) | Zhejiang Nysin Medical Co., Ltd. Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240632 — Neuvotion NeuStim NN-01 | Neuvotion, Inc. Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221326 — Nova Allegro HbA1c Assay, Nova Allegro Analyzer | Nova Biomedical Corporation Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241169 — Entarik NI Feeding Tube System | Gravitas Medical, Inc. Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242543 — Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) | Zimmer, Inc. Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242002 — FemVue MINI Saline-Air Device | Femasys, Inc. Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242094 — Dreem 3S | Beacon Biosignals, Inc. Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242913 — Jasmate® Toothpaste | Jasberry Healthcare Private Limited Fri Nov 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |