510(k) Clearances — Page 64
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K243255 — URIS Long Implant & Abutments | Truabutment, Inc. Thu Jul 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250448 — Disposable Percutaneous Nephrostomy Dilatation Kit | Shenzhen Trious Medical Technology Co., Ltd. Thu Jul 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250838 — Denudation Pipettes | Guangzhou Pinzhi Medical Device Co., Ltd. Thu Jul 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243123 — IPL Treatment Device (MDSQMC-01) | Medusa (Guangxi)Medical Devices Co., Ltd. Thu Jul 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250165 — Pastelle | Wontech Co., Ltd. Thu Jul 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243679 — MammoScreen® (4) | Therapixel Thu Jul 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251671 — Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems | Siemens Medical Solutions USA, Inc. Thu Jul 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250822 — SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse | Siemens Medical Solutions USA, Inc. Thu Jul 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250105 — Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) | Aveera Medical, Inc. Thu Jul 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250733 — 3DOSE 1ml Syringe | Bimed Teknik Aletler Sanayi & Ticaret A.S. Thu Jul 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243207 — BD Vacutainer® Eclipse Blood Collection Needle | Becton, Dickinson and Company Thu Jul 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251054 — Hem-o-lok PurplePlus Large Polymer Ligating Clips | Teleflex Medical Thu Jul 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243399 — Boehringer Laboratories Liver Retractor | Boehringer Laboratories, LLC Wed Jul 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251285 — Electric Wheelchair (HG-630) | Zhejiang Automwheel Tech Co., Ltd. Wed Jul 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251720 — OsteoFlo HydroFiber | SurGenTec, LLC Wed Jul 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250729 — Power Wheelchair (MOB1107) | Vive Health, LLC Wed Jul 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250279 — RC-SwiftPrep | Belport Company, Inc., Gingi-Pak Wed Jul 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251490 — 8 mm Assist Cannula; 12 mm Assist Cannula | Intuitive Surgical, Inc. Wed Jul 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243701 — AuroLase® System | Nanospectra Biosciences, Inc. Wed Jul 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250587 — Orthoscan TAU Mini C-Arm | Ziehm-Orthoscan, Inc. Wed Jul 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250779 — CS-Pro MED | Curative Sound Therapeutics Wed Jul 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250415 — G0 Blood Pressure Monitoring System (G0) | Aktiia SA Wed Jul 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243868 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | Pegavision Corporation Wed Jul 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250312 — Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small | Medline Industries, LP Wed Jul 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250524 — Mendaera Guidance System | Mendaera, Inc. Wed Jul 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251746 — Pure Impact | Sofwave Medical, Ltd. Wed Jul 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243468 — Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) | Joytech Healthcare Co. , Ltd. Wed Jul 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250391 — Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife® (Perfexion) | Elekta Solutions AB Wed Jul 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251049 — SurgiLight 1470 Diode Laser System (Model:Halo) | Micro-Energy Medical Technology Co., Ltd. Wed Jul 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251241 — EMPOWR Revision Knee (EMPOWR Revision Knee Symmetric TT Cones) | Encore Medical L.P. Wed Jul 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250684 — OPUSWAVE Dual Sensor Imaging System | Terumo Cardiovascular Systems Thi Plant Wed Jul 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250848 — Identity Shoulder System | Zimmer, Inc. Wed Jul 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251031 — Fiber Laser Treatment Systems (HS-232,HS-233) | Shanghai Apolo Medical Technology Co., Ltd. Wed Jul 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250699 — Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K) | Convatec Tue Jul 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243690 — SonoMSK | PAJUNK GmbH Medizintechnologie Tue Jul 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251212 — Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) | Access Vascular, Inc. Tue Jul 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251032 — MiniMed 780G insulin pump | Medtronic Minimed, Inc. Tue Jul 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250016 — droplet® personal lancets | Htl-Strefa S.A Tue Jul 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243485 — Alinity m CMV | Abbott Molecular, Inc. Tue Jul 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251453 — Arthrex iBalance Partial Knee System | Arthrex, Inc. Tue Jul 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243779 — Bunkerhill Abdominal Aortic Quantification (AAQ) | BunkerHill Health Tue Jul 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250221 — StrokeSENS ASPECTS Software Application | Circle Cardiovascular Imaging, Inc. Tue Jul 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251719 — Momentum® Posterior Spinal Fixation System | Ulrich Medical USA, Inc. Tue Jul 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250096 — Felix NeuroAI System | Fasikl Incorporated Tue Jul 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251933 — SnugFit ASA Extension | Medacta International S.A. Tue Jul 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250204 — Endoscopic Camera System | Shenzhen Sophway Technology Co., Ltd. Tue Jul 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250670 — EchoConfidence (USA) | Mycardium AI Limited Mon Jun 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250987 — aprevo® posterior/transforaminal lumbar interbody fusion device | Carlsmed, Inc. Mon Jun 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250022 — HeroTracker Sense | Voluntis Mon Jun 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250484 — PIUR tUS inside | Piur Imaging GmbH Mon Jun 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |