510(k) Clearances — Page 151
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K232140 — OTS Hip | Ortoma AB Mon Mar 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233912 — ARIX Cannulated Screw System | Jeil Medical Corporation Mon Mar 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234015 — Caphosol® Artifical Saliva (32 doses sachet box) | Eusa Pharma (Uk) Limited Mon Mar 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231864 — Fiber Optic Brushless Electronic Micromotor, model: iM100 | Codent Technical Industry Co., Ltd. Mon Mar 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233083 — Osteon Precision Milled Suprastructure | Implant Solutions Pty Ltd (Aka Osteon Medical) Sat Mar 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233359 — DOMINION Expandable Corpectomy System | Astura Medical Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230195 — Neo ADVISE software | Comerge AG Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233899 — Knee+ | Pixee Medical Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233649 — ALGO Pro Newborn Hearing Screener (ALGO Pro) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231813 — Ultrasonic Gastrovideoscope | Sonoscape Medical Corp. Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232826 — Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824) | Steris Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233177 — Nest VT Vitrification Device | Cook Incorporated Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231904 — Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard | Co-Innovation Biotech Co., Ltd. Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233758 — Trivicta Hip Stem | Ortho Development Corp. Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233038 — Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s | Edan Instruments, Inc. Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233438 — SleepStageML | Beacon Biosignals, Inc. Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240384 — SENDERO Microcatheter | Okami Medical, Inc. Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231056 — Esperance Distal Access Catheter | Wallaby Medical Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233421 — RESCAN 700 | Carl Zeiss Meditec, AG Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231760 — HP-OCT (HP-OCT) | Cylite Pty. , Ltd. Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231734 — STERiJECT Low Dead Space, STERiJECT The Invisible Needle | Tsk Laboratory International Japan KK Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240396 — Elite iQ PRO (M122K1) | Cynosure, LLC Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233198 — OSSIOfiber® Threaded Trimmable Fixation Nails | OSSIO , Ltd. Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233705 — CellFX Percutaneous Electrode System (SYS3000) | Pulse Biosciences, Inc. Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233943 — Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013) | Medtronic, Inc. Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240264 — Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A) | Shenzhen Mlay Intelligent Technology Co., , Ltd. Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234046 — WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System | Boston Scientific Corporation Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232207 — D·Kutting PTA Scoring Balloon Dilatation Catheter | Dk Medical Technology Co., Ltd. Thu Mar 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232781 — Safety Sliding Blood Collection Set | Jiangsu Caina Medical Co.,Ltd Thu Mar 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240458 — Synthetic Bone Putty | Ventris Medical Thu Mar 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233692 — Voluson Signature 20, Voluson Signature 18 | GE Medical Systems Ultrasound and Primary Care Diagnostics Thu Mar 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240407 — ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture Anchor | Stryker Endoscopy Thu Mar 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240371 — 0909FCC, 0909FCC-HS | Rayence Co., Ltd. Thu Mar 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232424 — CurrentBody Skin RF | El Global Trade, Ltd. Wed Mar 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231497 — Choledochoscope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. Wed Mar 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231403 — evoDrill Cranial Perforator | Evonos GmbH & Co. KG Wed Mar 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231677 — EdgeFlow UH10 | Edgecare, Inc. Wed Mar 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233794 — Insulin Syringe | Spm Medicare Pvt. , Ltd. Wed Mar 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233021 — BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device | Care Fusion Wed Mar 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240352 — Defendo Single Use Cleaning Adapter for Olympus Endoscopes | STERIS Corporation Wed Mar 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231786 — Gynethotics Pessary | Cosm Medical Wed Mar 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232270 — DVT Motion Pneumatic Compression Device | Koge Micro Tech Co., Ltd. Wed Mar 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233880 — Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141) | Shenzhen Root Innovation Technology Co., Ltd. Wed Mar 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233075 — BioGend Interbody Fusion System 001 Cage | Biogend Therapeutics Co., Ltd. Wed Mar 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240619 — e-SDF | Kids-E-Dental Llp Wed Mar 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233572 — Autofuse | Pymedix Wed Mar 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240273 — Access Free T4 | Beckman Coulter, Inc. Wed Mar 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232703 — Disposable Bipolar Forceps | Jiangsu Hope Biomedical Science & Technology Co., Ltd. Wed Mar 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232004 — Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector | Medivators (A Subsidiary of Steris Corporation) Wed Mar 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240351 — FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) | Assure Tech., LLC Wed Mar 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |