510(k) Clearances — Page 164
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K233681 — ConFirm 20 Minute Incubator | STERIS Corporation Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233564 — FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) | Fluoptics Sas (A Getinge Group Company) Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232939 — IPL Hair Removal Device | Shenzhen Borria Technology Co., Ltd. Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231447 — Double Internal Joint Stabilizer- Elbow | Skeletal Dynamics, Inc. Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233682 — VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE | STERIS Corporation Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231700 — Ziehm Vision FD | Ziehm Imaging GmbH Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231478 — Digital Blood Pressure Monitor (Model: YB-800) | Wenzhou Yosun Medical Technology Co.,Ltd Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233607 — MagnetOs Easypack Putty | Kuros Biosciences B.V Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230949 — ARTIS pheno (VE30A) | Siemens Medical Solutions USA, Inc. Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232130 — Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter | Surgical Instrument Services and Savings, Inc. Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231160 — Cardio Q50, Cardio Q70 | Bionet Co., Ltd. Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232267 — Precice Max System | Nuvasive Specialized Orthopedics, Incorporated Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232887 — Invisalign Palatal Expander System | Align Technology, Inc. Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233182 — Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue) | Zibo Kaiyue Mould Technology Co., Ltd. Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230751 — EW10-EC02 Endoscopy Support Program | Fujifilm Corporation Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232598 — Unscented Menstrual Tampon | Unibeauty (Hubei) Technology Co., Ltd. Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223721 — Masimo Stork | Masimo Corporation Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230501 — Spirobank Oxi | Mir Medical International Research USA Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233237 — xeo+ Family | Cutera, Inc. Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230050 — Body Temperature Software (BTS) | Fitbit, LLC Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232957 — Sterile and Non-Sterile Ultrasound Gels | Jianerkang Medical Co., Ltd. Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231645 — PherDal® At-Home Insemination Kit | Pherdal Fertility Science, Inc. Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232580 — Disposable Endobronchial Blocker Tube | Shenzhen Insighters Medical Technology Co., Ltd. Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231181 — bright CT | Dentium Co., Ltd (Ict Branch) Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223470 — C50 | Sopro Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233374 — Secret Pro | Ilooda Co,., Ltd. Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232283 — PhySoftAMS® | Physician Software Systems, LLC Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233670 — Ascension Silicone MCP; Ascension Silicone PIP | Ascension Orthopedics, Inc. Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230950 — ARTIS icono (VE30A) | Siemens Medical Solutions USA, Inc. Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231801 — MedHealth DVT compression Devices MHH900S/MHH900E | Medhealth Medical Limited Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232875 — Vial Adapter 20mm | West Pharma. Services IL, Ltd. Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231721 — Disposable Hot Biopsy Forceps | Beijing Zksk Technology Co., Ltd. Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231570 — StrokeViewer Perfusion | Nico-Lab B.V. Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231887 — ARIX Ankle Distal Tibia System | Jeil Medical Corporation Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233227 — VELYS Robotic-Assisted Solution | Depuy Ireland UC Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232401 — Disposable Veress Needles | Hangzhou Kangji Medical Instrument Co., Ltd. Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233648 — Millipede 088 Access Catheter | Perfuze, Ltd. Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233647 — VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232455 — SofWave System | Sofwave Medical, Ltd. Thu Dec 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233594 — Genesys Spine 3DP AIS-C II Cervical Interbody System | Genesys Spine Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231666 — Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) | FUJIFILM Healthcare Americas Corporation Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232877 — FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C Stand Alone System | K&J Consulting Corporation Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232659 — Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup | Guangzhou Decheng Biotechnology Co., Ltd. Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231614 — MiroTract Wound Matrix | Reprise Biomedical, Inc. Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232680 — fMRI Hardware System | Nordicneurolab AS Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230964 — Power Wheelchair (N5909) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231870 — CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System | Ge Medical Systems Information Technologies, Inc. Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233019 — AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx | Hangzhou AllTest Biotech Co., Ltd. Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231803 — Neodent Implant System - Zirconia Implant System | JJGC Indústria e Comércio de Materiais Dentários S.A. Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230852 — HemosIL Chromogenic Factor IX | Instrumentation Laboratory Company Wed Dec 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |