510(k) Clearances — Page 109
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K242261 — Accelx Implant System | Biotech Dental, LLC Wed Nov 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242412 — Agility Symmetric Total Knee System | Medisurge, LLC Wed Nov 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243106 — CarboClear® Hybrid Pedicle Screw System | CarboFix Orthopedics , Ltd. Tue Nov 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242664 — gentleheel® Adult Incision Device | Gri-Alleset, Inc. Tue Nov 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241312 — TeraRecon Cardiac.Chambers.MR (1.0.0) | Terarecon,Inc. Tue Nov 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243015 — Skyway Anterior Cervical Plate System | Kyocera Medical Technologies, Inc. Tue Nov 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240624 — InfuLife | First Medical Source, LLC Tue Nov 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241484 — Atlas Humeral Nail System | Orthopedic Designs North America, Inc. (Odi-Na) Tue Nov 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241849 — MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) | Imaxeon Pty, Ltd. Tue Nov 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242332 — Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494) | Shenzhen Kentro Medical Electronics Co., Ltd. Tue Nov 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242345 — Delphi Stimulator | Quantalx Neuroscience Tue Nov 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231287 — POTENZA | Jeisys Medical, Inc. Tue Nov 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242340 — DESS Dental Smart Solutions | Terrats Medical SL Tue Nov 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242947 — FreedomFlow Orbital Circumferential Atherectomy System | Cardio Flow Inc., Tue Nov 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243061 — SonoStik Guide Wire Introducer | Sonostik, LLC Mon Nov 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240512 — Tixel i (TXLI0001) | Novoxel , Ltd. Mon Nov 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242567 — Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C) | Changsha Anxiang Medical Technology Co., Ltd. Mon Nov 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242709 — JLK-PWI | JLK, Inc. Mon Nov 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240438 — CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm) | Comercializadora Brever Mon Nov 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230083 — Valeda Light Delivery System | Lumithera, Inc. Mon Nov 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242195 — Gemini Cervical Fusion Cage System | ZheJiang Decans Medical Devices Co., Ltd. Mon Nov 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240637 — RIGHTEST Blood Glucose Monitoring System Max Tel | Bionime Corporation Mon Nov 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243217 — Legend X Desktop System | Pollogen, Ltd. Fri Nov 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241068 — uDR 780i | Shanghai United Imaging Healthcare Co., Ltd. Fri Nov 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242620 — Breo Laser Hair Growth Comb (Scalp 3L) | Shenzhen Breo Technology Co., Ltd. Fri Nov 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242320 — BD Vacutainer® One Use Holder | Becton, Dickinson and Company Fri Nov 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242393 — Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lenses | Acuity Polymers, Inc. Fri Nov 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242076 — VersaCross RF Wire | Baylis Medical Company Fri Nov 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242665 — DePuy ATTUNE Total Knee System | Depuy Orthopedics, Inc. Fri Nov 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242311 — EXPERT - Flexible Joint Fixation System | GM Dos Reis Industria e Comercio Ltda. Fri Nov 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241828 — Affera Integrated Mapping System; Impedance Localization Patch Kit | Medtronic, Inc. Fri Nov 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242675 — FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) | Spident Co., Ltd. Fri Nov 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242591 — XERO-alpha | DRTECH Corporation Fri Nov 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242269 — SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) | Quanta Dialysis Technologies, Ltd. Fri Nov 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241646 — ORTIV (ORTIV-BL, ORTIV-WH) | Mvitro Co., Ltd. Fri Nov 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242452 — Monkey Bars Pin to Bar External Fixation System | Paragon 28, Inc. Fri Nov 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243091 — Over-tube (TR-1108A) | Fujifilm Corporation Fri Nov 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240514 — AMT Low-Profile Suprapubic Catheter & Drainage Set | Applied Medical Technology, Inc. Fri Nov 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243381 — Total Wrist Arthroplasty System (TWA) | Skeletal Dynamics, Inc. Fri Nov 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240366 — EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional Steerable Diagnostic Catheter; Dynamic XT Unidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation Fri Nov 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240881 — Signia Circular Adapter (Standard Length) (SIGCIRSTND); Signia Circular Adapter XL Length (SIGCIRXL) | Covidien (Part of Medtronic) Fri Nov 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241999 — Prophecy Surgical Planning System | Wright Medical Technology, Inc. (Stryker) Fri Nov 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240388 — Osteotomy Truss System (OTS) | 4Web Medical, Inc. Fri Nov 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240383 — Highness Implant System | Highness Co., Ltd. Thu Oct 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242623 — Disposable Blood Pressure cuff; Reusable Blood Pressure cuff | Shenzhen Medke Technology Co., Ltd. Thu Oct 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241223 — eRAD PACS | Erad, Inc. Thu Oct 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240455 — BD Vacutainer® Citrate Blood Collection Tubes | Becton, Dickinson and Company Thu Oct 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240653 — SmartCardia 7L Platform (MCT) | Smartcardia SA Thu Oct 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243181 — Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo | Bionova Medical, Inc. Thu Oct 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242328 — PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports | Bard Access Systems, Inc. Thu Oct 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |