510(k) Clearances — Page 52
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K250040 — uWS-Angio | Shanghai United Imaging Healthcare Co., Ltd. Fri Sep 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243864 — BONX805 | Bontech Co., Ltd. Fri Sep 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250059 — BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O) | Becton, Dickinson and Company Fri Sep 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250047 — bite away two | mibeTec GmbH Fri Sep 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252586 — CADDIE | Odin Medical Limited Fri Sep 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252189 — LED Light Therapy Mask (2311, 2344, 2457, 2458) | Dongguan Yanxi Technology Co., Ltd. Fri Sep 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252576 — Legend X Platform | Pollogen, Ltd. Fri Sep 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250445 — Fast Warm - NX | Fujifilm Irvine Scientific Fri Sep 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252554 — Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup | Vivachek Biotech (Hangzhou) Co., Ltd. Fri Sep 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250986 — S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) | Mevion Medical Systems, Inc. Fri Sep 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252562 — Spine & Trauma Navigation Instruments | Brainlab AG Fri Sep 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250628 — DynaNail TTC Fusion System | MedShape, Inc. Fri Sep 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251083 — Compact II | Enraf-Nonius, B.V. Fri Sep 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251518 — Volta AF-Xplorer II | Volta Medical Fri Sep 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251368 — FETOLY | Diagnoly Fri Sep 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251843 — Erchonia EVRL | Erchonia Corporation Fri Sep 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242314 — Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) | Augment Intelligent Medical System (China) Co., Ltd. Thu Sep 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250507 — Hypertension Notification Feature (HTNF) | Apple, Inc. Thu Sep 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251158 — PowerWire® 14 Radiofrequency Guidewire Kit | Baylis Medical Technologies, Inc. Thu Sep 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250797 — UV5000 Handle | Uroviu Corporation Thu Sep 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251320 — XTRA4 | Al.Chi.Mi.A. S.R.L Thu Sep 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250216 — OsteoProbe (OP-100) | Active Life Scientific, Inc. Thu Sep 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251758 — Serafin® | Tns Co., Ltd. Thu Sep 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252374 — Nylon flexTAP(R) | Airway Technologies D/B/A Airway Management Thu Sep 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251316 — Mazor X System / Mazor X Stealth Edition | Mazor Robotics , Ltd. Thu Sep 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243926 — Vivatmo pro-S | Bosch Healthcare Solutions GmbH Thu Sep 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251826 — RENASYS WOUND+ Dressing Kit with AIRLOCK Technology | Smith & Nephew Medical, Ltd. Thu Sep 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252520 — SEFRIA Hydrocodone Oral Fluid | Immunalysis Corporation Thu Sep 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251399 — SIGNA Sprint | Ge Medical Systems, LLC Thu Sep 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251573 — VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens | Vizionfocus, Inc. Wed Sep 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252173 — F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full | Fisher & Paykel Healthcare, Ltd. Wed Sep 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250734 — OptiLUV Device | Pollogen, Ltd. Wed Sep 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252530 — OptiVu Shoulder | Mr Surgical Solutions, LLC Wed Sep 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244002 — AngioWaveNet | Angiowave Imaging, Inc. Wed Sep 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252527 — Surfacer Inside-Out Access Catheter System | Merit Medical System, Inc. Wed Sep 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252580 — iQ200 Series | Beckman Coulter, Inc. Wed Sep 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250464 — Enlight 2100 (TPL-E2103-0) | Timpel S.A. Wed Sep 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251817 — da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. Wed Sep 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251773 — Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.) | Shenzhen Yongquan Medical Devices Co., Ltd. Tue Sep 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252477 — Hybrid Viewer (00859873006240) | Hermes Medical Solutions AB Tue Sep 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251682 — MuscleView 2.0 | Springbok, Inc. (Dba Springbok Analytics) Tue Sep 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250483 — PhotonBlade 3; PhotonBlade 3 Smoke Evacuation | Stryker Instruments Tue Sep 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252524 — Quadsense (Quadsense and Quadsense Pro) | Eventum Orthopaedics, Ltd. Tue Sep 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252608 — AI-Rad Companion Prostate MR | Siemens Healthcare GmbH Tue Sep 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243846 — Access anti-HAV | Beckman Coulter, Inc. Tue Sep 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251040 — MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test | Guangzhou Decheng Biotechnology Co., Ltd. Tue Sep 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251072 — Segmentron Viewer | DGNCT, LLC Tue Sep 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250922 — Edema Guard Monitor (EGM) CardioSet-001 | Cardioset Medical , Ltd. Tue Sep 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252181 — AquaA | Fresenius Medical Care North America Tue Sep 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251891 — Electric Wheelchair (GY-E001) | Shandong Guyue Healthcare Appliance Co., Ltd. Tue Sep 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |