510(k) Clearances — Page 61
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K243373 — Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511) | Vitrolife Sweden AB Wed Jul 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250211 — Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. Tue Jul 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251300 — Plastic Surgical Kits | Dentsply Sirona, Inc. Tue Jul 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243367 — Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) | Minnesota Medical Technologies Tue Jul 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244018 — Disposable Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. Tue Jul 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251505 — VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) | Alafair Biosciences Tue Jul 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243566 — CardioTag | Cardiosense, Inc. Tue Jul 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251310 — OTS 25-L (100-5) | Ots Medical , Ltd. Tue Jul 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243415 — Granudacyn® Wound Irrigation Solution | P.G.F. Industry Solutions GmbH Tue Jul 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251616 — Clear Miracle | Ods Co., Ltd. Tue Jul 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251638 — Mobility Scooter (MS160C) | Suzhou Master Machinery Manufacturing Co.,Ltd Tue Jul 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250901 — Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation Tue Jul 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250686 — GyriCalc (Version 1.0.0) | Neurospectrum Insights Corp. Tue Jul 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251255 — LymphaTech Mobile 3D Measuring Tool | Lymphatech, Inc. Tue Jul 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243425 — Guided DAS Surgical Kit | Talladium España, SL Tue Jul 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243432 — Vascular Navigation PAD 2.0; Navigation Software Vascular PAD | Brainlab AG Tue Jul 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251564 — microINR System | Iline Microsystems, S.L. Mon Jul 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250913 — TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System | Jiangsu Tingsn Technology Co., Ltd. Sat Jul 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251906 — Z1 Hip System | Zimmer, Inc. Fri Jul 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252218 — MF SC GEN2 Facial Toning System | Micro Current Technology, Inc. Fri Jul 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250750 — INNOVISION-P5 | Dk Medical Systems Co., Ltd. Fri Jul 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250902 — HeartFlow Analysis | HeartFlow, Inc. Fri Jul 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250952 — Baby Gorilla®/Gorilla® Plating System | Paragon 28, Inc. Fri Jul 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243404 — HyHub and HyHub Duo Vial Access Devices | Takeda Pharmaceuticals Fri Jul 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251585 — Profoject Enteral Feeding Syringe | CMT Health PTE., Ltd. Fri Jul 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252012 — SPY Cystoscope/Hysteroscope | Stryker Endoscopy Fri Jul 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251655 — VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) | Alafair Biosciences Fri Jul 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251809 — Arthrex FiberTak Suture Anchor | Arthrex, Inc. Fri Jul 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243775 — True Non-Surgical Spinal Decompression System (DRX9000-SL) | Excite Medical of Tampa Bay, LLC Fri Jul 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250999 — V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. Fri Jul 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250084 — MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL) | Beckman Coulter, Inc. Fri Jul 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231562 — ELEC ENGINE (Model: ISE-170L) | Micro-Nx Co., Ltd. Fri Jul 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251542 — InstaFAN | Onepass Medical , Ltd. Fri Jul 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250553 — Tomey Cornea/Anterior Segment OCT (CASIA2) | Tomey Corporation Fri Jul 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243547 — uMR Ultra | Shanghai United Imaging Healthcare Co., Ltd. Thu Jul 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243324 — Masimo O3 Regional Oximeter | Masimo Corporation Thu Jul 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251175 — VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) | Alafair Biosciences Thu Jul 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250751 — DualView Catheter | Terumo Corporation Thu Jul 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243420 — HESTIA | Genoray Co., Ltd. Thu Jul 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242505 — Elecsys Cortisol III | Roche Diagnostics Thu Jul 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251016 — MectaLIF 3D Metal | Medacta International S.A. Thu Jul 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243756 — 0.014 Willow Guidewire | Arbor Endovascular, LLC Thu Jul 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243428 — e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector | Dxtx Medical, Inc. Thu Jul 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251556 — Device 300423 Granules | Geistlich Pharma AG Thu Jul 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251491 — K5 Cart, K5 Mount, K5 Swing | Osstem Implant Company., Ltd. Chair Business Thu Jul 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251839 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | Shanghai United Imaging Healthcare Co., Ltd. Thu Jul 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251102 — Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L, CH-S693L, CH-B601L, CP-B01, CH-S603) | Cemho Medical Technology (Guangdong) Co., Ltd. Wed Jul 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251342 — EchoPAC Software Only / EchoPAC Plug-in | GE Medical Systems Ultrasound and Primary Care Diagnostics Wed Jul 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251151 — Rapid CTA 360 | Ischemaview Wed Jul 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251198 — HyperVue Software | Spectrawave, Inc. Wed Jul 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |