510(k) Clearances — Page 86
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K242997 — MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. Thu Mar 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243735 — Ziehm Vision FD | Ziehm Imaging GmbH Thu Mar 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250385 — Turbo-Elite Laser Atherectomy Catheter | Spectranetics Thu Mar 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242406 — SiOxC Cream | Sioxmed, LLC Thu Mar 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250255 — xvision Spine system | Augmedics, Ltd. Thu Mar 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250113 — neoLaser Laser Surgery Fibers | G.N.S Neolaser , Ltd. Thu Mar 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241811 — MedCAD® AccuStride System | Medcad Thu Mar 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250382 — Freedom Total Knee System (All-poly Tibial Plate) | Maxx Orthopedics, Inc. Thu Mar 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243993 — Photon Therapy Apparatus (BL-10) | Xemis Medical Technology (Shenzhen) Co., Ltd. Thu Mar 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243487 — CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. Thu Mar 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243903 — RCT600 | Ray Co., Ltd. Wed Mar 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243763 — Wireless TENS & EMS Unit | Changsha Anxiang Medical Technology Co., Ltd. Wed Mar 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243783 — Walking rehabilitation training electric wheelchair (ZW518) | Shenzhen Zuowei Technology Co., Ltd. Wed Mar 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250605 — EVOL® ha Hyper C Cervical Interbody Fusion System | Cutting Edge Spine, LLC Wed Mar 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250411 — DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System | Dannik, LLC Wed Mar 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243957 — PICOALEX | Wontech Co., Ltd. Wed Mar 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243849 — 2430TCA with Xmaru W | Rayence Co., Ltd. Wed Mar 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241822 — ReWalk® 7 Personal Exoskeleton (50-20-0005) | Rewalk Robotics Ltd. Dba Lifeward Wed Mar 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243822 — BioFire Warrior Panel; BioFire Warrior Panel Control Kit | Biofire Defense, LLC Wed Mar 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243746 — Delphi Amplifier | Quantalx Neroscience Wed Mar 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250357 — RemunityPRO Pump for Remodulin® (treprostinil) Injection | Deka Research & Development Corp. Tue Mar 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242610 — 8mm Monopolar Curved Scissors (470179) | Iconocare Health Tue Mar 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241725 — Better Diagnostics Caries Assist (BDCA) Version 1.0 | Better Diagnostics AI Corp. Tue Mar 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250424 — Arthrex TightRope Soft Button, RT | Arthrex, Inc. Tue Mar 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243029 — Origin TT Stem | Signature Orthopaedics Pty, Ltd. Tue Mar 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241562 — OutFlo Aortic Valve Dilatation Balloon Catheter | Disa Medinotec Tue Mar 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250374 — iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R | Stryker Instruments Tue Mar 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243596 — da Vinci SP SureForm 45 Staplers and Reloads (SP1098) | Intuitive Surgical, Inc. Mon Mar 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241944 — AGILON® XO Shoulder Replacement System | Implantcast GmbH Mon Mar 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243676 — Duet External Drainage and Monitoring System (EDMS) | Medtronic Neurosurgery Mon Mar 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250188 — Wound Treatment System (VHT-200) | Vaporox, Inc. Mon Mar 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243101 — Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342) | Surgical Instrument Service and Savings, Inc. Mon Mar 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243839 — Alteon® HA Femoral Stems | Exactech, Inc. Mon Mar 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242338 — Cleerly LABS (v2.0) | Cleerly, Inc. Fri Mar 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242510 — Geistlich Bio-Flow® | Geistlich Pharma AG Fri Mar 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243421 — Lelo Hex Lubricated Natural Rubber Latex Condom | Lelo, Inc. Fri Mar 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242890 — SPINEART Navigation Instrument System | Spineart SA Fri Mar 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243970 — Portable Wheelchair | Intradin (Shanghai) Machinery Co., Ltd. Fri Mar 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243610 — APTUS Hand System; APTUS Elbow Dorsal Olecranon | Medartis AG Fri Mar 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242914 — Op.n(TM) Navigation | Ecential Robotics Fri Mar 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243535 — Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) | Shanghai SeeGen Photoelectric Technology Co., Ltd. Fri Mar 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242642 — CuffTrek | Shanghai Longmann Tech Co., Ltd. Fri Mar 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243798 — Orthex External Fixation System | OrthoPediatrics Corp. Fri Mar 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243515 — EpiWatch Monitoring System | Epiwatch, Inc. Fri Mar 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241799 — ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C | Atmos Medizintechnik GmbH & Co. KG Fri Mar 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242383 — Apex Locator | Shenzhen Rogin Medical Co., Ltd. Fri Mar 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243801 — FRONT-LINE Field Sterilizer (FL135) | Fort Defiance Industries, LLC Fri Mar 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241159 — Handbike Batec Electric | Batec Mobility, S.L. Fri Mar 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242207 — NOABLE LASER | Daeju Meditech Engineering Co., Ltd. Fri Mar 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241790 — XCELLARISPRO TWIST microneedling device | Dermaroller GmbH Thu Mar 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |