510(k) Clearances — Page 74
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K250110 — Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic Ultrasound System (MX6T); Diagnostic Ultrasound System (MX6 Exp); Diagnostic Ultrasound System (MX6 Pro); Diagnostic Ultrasound System (MX6 Super); Diagnostic Ultrasound System (MXG); Diagnostic Ultrasound System (Emerus MX6); Diagnostic Ultrasound System (Emerus MX6 Exp); Diagnostic Ultrasound System (Anesus MX6); Diagnostic Ultrasound System (Anesus MX6 Exp); Diagnostic Ultrasound System (Crius MX6); | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Fri May 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243371 — Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 | Byonyks Pvt, Ltd. Fri May 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242438 — Clearo | Breas Medical AB Fri May 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250086 — OTS Hip | Ortoma AB Fri May 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251184 — AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System | Encore Medical L.P. Fri May 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243837 — iBSM | Iorbit Digital Technologies Private Limited Fri May 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240554 — InferRead Lung CT.AI | Infervision Medical Technology Co., Ltd. Fri May 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244008 — Spectral CT | Philips Medical Systems Technologies , Ltd. Fri May 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250141 — Synthecure Synthetic Calcium Sulfate | Austin Medical Ventures, Inc. Fri May 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243602 — Arthrex Spine Endoscope | Arthrex, Inc. Fri May 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243176 — BLESSING System | Cellah Medical Co., Ltd. Fri May 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243927 — MobileLink Acetabular Cup System - inhouse coatings | Waldemar Link GmbH & Co. KG Fri May 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242569 — Mixed Reality Spine Navigation | Brainlab AG Fri May 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250099 — Mobius3D (4.1) | Varian Medical Systems Fri May 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242519 — Lumify Diagnostic Ultrasound System | Philips Ultrasound Thu May 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) | C.R. Bard, Inc. Thu May 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243165 — Limfa Therapy System (Limfa Therapy) | Eywa Srl Thu May 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250432 — Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500) | Olympus Medical Systems Corporation Thu May 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250444 — NEXUS® Hip Stem | Microport Orthopedics, Inc. Thu May 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250276 — Nitinol Enhanced Device (NED) | Embolization, Inc. Thu May 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250451 — NeurAxis IB-Stim (01-1020) | Neuraxis Thu May 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242176 — BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U) | NIKKISO CO., LTD. Thu May 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250454 — HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) | Hardy Diagnostics Thu May 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251156 — NPseal | Guard Medical, Inc. Thu May 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242479 — BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU | NIKKISO CO., LTD. Thu May 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240857 — Youmagic FLM System (YM5-U1) | We Medical Technology (Wuxi) Co., Ltd. Thu May 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242518 — Hypertension Prediction Index (HePI) Algorithm | Edwards Lifesciences, LLC Thu May 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250213 — OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit) | Stryker Instruments Thu May 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242931 — HFT750U | Mekics Co., Ltd. Thu May 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242155 — DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) | NIKKISO CO., LTD. Thu May 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250813 — MICROLET®NEXT 2 Lancing Device | Ascensia Diabetes Care U.S., Inc. Wed May 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250533 — Magnesium alloy scooter (RS100) | Taizhou Reach Technology Co., Ltd. Wed May 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243830 — Disposable ureteral stent | Shenzhen Trious Medical Technology Co., Ltd. Wed May 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242072 — CeraRoot TL Implant System (TL) | Ceraroot SL Wed May 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250420 — Helios Dura Regeneration Matrix | Helios Biomedical, Inc. Wed May 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251288 — Veincare | Wontech Co., Ltd. Wed May 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250414 — CaloPix | Tribun Health Wed May 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250405 — Nerivio; Nerivio Infinity | Theranica Bio-Electronics, Ltd. Wed May 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250835 — ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T) | Ethicon Endo-Surgery, LLC Wed May 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242624 — Medical Image Post-processing Software (uOmnispace.CT) | Shanghai United Imaging Healthcare Co., Ltd. Wed May 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250041 — Medical Picosecond ND: YAG Laser System (PZ-6) | Zhengzhou PZ Laser Slim Technology Co., Ltd. Wed May 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250712 — Linkt Compression Staple System | Trax Surgical Wed May 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250775 — Symphony Thrombectomy System; Symphony 16F 82cm Thrombectomy System | Imperative Care, Inc. Wed May 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242437 — Smile Dx® | Cube Click, Inc. Wed May 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251138 — Promisemed Safety Huber Needles | Promisemed Hangzhou Meditech Co., Ltd. Tue May 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242762 — Aesculap Aicon® Series Container System | Aesculap, Inc. Tue May 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250786 — SP Endoscope, 0° (430600) | Intuitive Surgical, Inc. Tue May 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250418 — Ulthera System (UC-1 Control Unit PRIME Model 2.1) | Ulthera, Inc. Tue May 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242674 — Freedom Posterior Cervical Screws | Signature Orthopaedics Pty, Ltd. Tue May 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242808 — Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 | Canon Medical Systems Corporation Tue May 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |