510(k) Clearances — Page 75
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K250592 — NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) | Northeast Scientific, Inc. Mon May 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250763 — Reon | C.E.I.B.Med Mon May 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242418 — P-Cure Proton Therapy System (PPTS) | P-Cure, Ltd. Mon May 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250431 — Medical Diode Laser Hair Removal System (MNLT-D1) | Shandong Moonlight Electronics Tech Co., Ltd. Mon May 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250868 — SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH Mon May 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244050 — AYON Body Contouring System (AYON SYSTEM) | Apyx Medical Corporation Mon May 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250393 — ZircaGlow & ZircaGlow HT Zirconia | United Zirconia Mon May 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242477 — Shoulder Soft Tissue Anchors | Signature Orthopaedics Pty, Ltd. Mon May 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250421 — InThrill Thrombectomy System | Inari Medical, Inc. Mon May 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243509 — Archer PSI System | 3D-Side Mon May 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243632 — uWS-Angio Basic | Shanghai United Imaging Healthcare Co., Ltd. Mon May 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250360 — TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026) | Shenzhen Jiantuo Electronics Co., Ltd. Sun May 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250377 — Flowflex Plus COVID-19 + Flu A/B Home Test | ACON Laboratories, Inc. Sat May 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN240045 — Teal Wand | Teal Health, Inc. Fri May 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251126 — SKOUT system | Iterative Health Fri May 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250053 — TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B) | Shenzhen Jiantuo Electronics Co., Ltd. Fri May 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242732 — Tristel OPH | Tristel Solutions , Ltd. Fri May 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242294 — DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls | Diasys Diagnostic Systems GmbH Fri May 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250758 — Electric Wheelchair (F309) | Changshu Pingfang Wheelchair Co., Ltd. Fri May 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242388 — LensHooke X12 PRO Semen Analysis System | Bonraybio Co., Ltd. Fri May 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251110 — EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Philips Ultrasound, LLC Fri May 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243107 — Water Solubility Human Body Lubricant | Dongguan Yanxuan Biotechnology Co., Ltd. Fri May 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243322 — Altaviz Intravitreal Syringe | Altaviz, LLC Fri May 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250400 — Vigeon Laparoscopic Universal Smoke Evacuator (VG003) | Vigeon Technology Co., Ltd. Fri May 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251103 — VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) | Philips Image Guided Therapy Corporation Fri May 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243812 — Volta AF-Xplorer | Volta Medical Fri May 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251425 — turbodent touch | Mectron S.P.A. Fri May 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241086 — Avidhrt Sense SpO2 | Avidhrt, Inc. Fri May 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242692 — SteadiSet Infusion Set | Capillary Biomedical, LLC Fri May 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243290 — BTL-785MJ | BTL Industries, Inc. Fri May 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242392 — PATH BGC | Crossroads Neurovascular, Inc. Fri May 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243230 — Second Opinion® BLE | Pearl, Inc. Fri May 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250299 — CT/ MR Tandem and Ovoid Set | Varian Medical Systems, Inc. Fri May 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242670 — Lumify Diagnostic Ultrasound System | Philips Ultrasound Thu May 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243110 — eFOLDi Navigator Powerchair (STPC-A) | Suntech UK , Ltd. Thu May 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250482 — Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue | Fissiontech, LLC Thu May 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250226 — Clarius Median Nerve AI | Clarius Mobile Health Corp. Thu May 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243764 — Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) | Wuhan Pioon Technology Co., Ltd. Thu May 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243824 — Preat Abutments | Preat Corporation Thu May 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243419 — Altus Spine Navigation System | Altus Partners, LLC Thu May 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243226 — Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series) | Leltek, Inc. Thu May 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242410 — NextStep Arthropedix Total Knee System | Nextstep Arthropedix Thu May 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250582 — COLONNADE Posterior Screw Fixation System | CG Bio Co., Ltd. Thu May 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251133 — AVEA disposable expiratory filter/water trap (11790) | Telesair, Inc. Thu May 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233271 — OsseOne Dental Implant System | Synoross Dba Osseone Thu May 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251128 — Extremity Medical External Fixation System | Extremity Medical, LLC Wed May 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243684 — BrightHeart View Classifier | Brightheart Wed May 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251111 — Cary | Excitus AS Wed May 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250222 — SDF Pro | Belport Company, Inc., Gingi-Pak Wed May 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242975 — Mobility Scooter (Model X-01, X-02) | Wuyi Aichi Industry & Trade Co., Ltd. Wed May 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |