510(k) Clearances — Page 95
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K242935 — Respiration Data Management Software (PAP Link PC) | BMC Medical Co., Ltd. Wed Jan 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242667 — AeroChamber2go Anti-Static Valved Holding Chamber | Trudell Medical International Wed Jan 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243284 — RELiZORB (100300/ 100301) | Alcresta Therapeutics, Inc. Wed Jan 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243858 — TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge | Haemonetics Corporation Wed Jan 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243946 — EffortMed Spinal Fixation System | Effortmed, LLC Wed Jan 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242873 — Ventrax Delivery System | Merit Medical Systems, Inc. Wed Jan 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243065 — Cardiac Guidance | Caption Health, Inc. Wed Jan 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241096 — Venera 608 Deep Vein Thrombosis (DVT) Prevention System | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. Wed Jan 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243573 — FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream | Assure Tech., LLC Wed Jan 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242634 — PuraStat | 3-D Matrix Europe SAS Wed Jan 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242541 — GEM ZIPCLIP | Synovis Micro Companies Alliance A Subsidiary of Baxter Int Wed Jan 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243569 — TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wrist Fixation System (Hook Plates); TriMed Wrist Fixation System (Pin Plates); TriMed Wrist Fixation System (Peg Plates); TriMed Wrist Fixation System (Shear Plates); TriMed Wrist Fixation System (Wireform plates and Washer); TriMed Wrist Fixation System (Wireforms); TriMed Wrist Fixation System (Torx Cortical Screws); TriMed Wrist Fixation System (Torx Threaded Pegs); | TriMed, Inc. Wed Jan 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243328 — Ziehm Vision RFD | Ziehm Imaging GmbH Wed Jan 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241037 — ABL90 FLEX PLUS System | Radiometer Medicals Aps Tue Jan 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242672 — Zoom System | Imperative Care, Inc. Tue Jan 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241066 — BB-613-BPM | Biobeat Technologies , Ltd. Tue Jan 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241166 — uCT 550 | Shanghai United Imaging Healthcare Co., Ltd. Tue Jan 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243297 — APRO 70 Swift Catheter | Alembic, LLC Tue Jan 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243452 — Orthoscan VERSA Mini C-Arm | Ziehm-Orthoscan, Inc. Tue Jan 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243272 — LOCATOR Angled Abutment | Zest Anchors, LLC Tue Jan 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242205 — SpectoMed (v1.0) | Specto Medical Tue Jan 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241180 — Consensus Knee System with TiNbN | Shalby Advanced Technologies Tue Jan 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243904 — Elegance® Anterior Cervical plate | Clariance Tue Jan 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241278 — ASEPT® Glide Peritoneal Drainage System | Pfm Medical, Inc. Tue Jan 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243577 — Radical the Dude 8F Guide Catheter | Maduro Medical, Inc. Tue Jan 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241200 — SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option | Arineta , Ltd. Mon Jan 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242030 — MegaGen Dental Implant Abutment | Megagen Implant Co., Ltd. Mon Jan 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243950 — ARVIS® Shoulder | Kico Knee Innovation Company Pty, Ltd. Mon Jan 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243533 — Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus | Hlb Co., Ltd. Healthcare Mon Jan 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243890 — Arthrex Intramedullary Nails | Arthrex, Inc. Mon Jan 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233452 — Vivo 45 LS | Breas Medical AB Mon Jan 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243295 — Initia Knee System | Kyocera Medical Technologies, Inc. Mon Jan 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243791 — Air Pressure Therapy System | Xiamen Weiyou Intelligent Technology Co., Ltd. Mon Jan 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243527 — High Flow Insufflation Unit (UHI-4) | Olympus Medical Systems Corporation Mon Jan 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243262 — QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test | Osang, LLC Mon Jan 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243271 — MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Enhance Single Use Gel Sizer | Mentor Worldwide, LLC Mon Jan 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243909 — Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric | Alcon Laboratories, Inc. Mon Jan 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241059 — Pantheon Proximal Femur Reconstruction (PFR) System | Adler Ortho S.P.A Mon Jan 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242680 — LetsGetChecked Impress | Privapath Diagnostics Ltd (Dba Letsgetchecked) Mon Jan 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241431 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193) | Joytech Healthcare Co. , Ltd. Mon Jan 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242689 — AAMI Level 4 Protective; Gown | Azac Group Mon Jan 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243836 — Mentor CPX 4 PLUS Enhance Breast Tissue Expander | Mentor Worldwide, LLC Sun Jan 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241641 — Electric Wheelchair (YE200) | Shenzhen Yattll Industry Co., Ltd. Sat Jan 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241891 — ScreenDx | Imvaria, Inc. Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243492 — Ulike Reglow Light Therapy Device (UM10) | Shenzhen Ulike Smart Electronics Co., Ltd. Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242767 — Safecare Urinary Tract Infection Test | Safecare Biotech (Hangzhou) Co., Ltd. Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242901 — ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN GBT Orogastric Tube - 40 Fr (ZZ-GBT-40) | Tools For Surgery, LLC Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243111 — Bowhead ERA Wheelchairs | Bowhead Design Corp. Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241781 — Solo Pace Control | Solo Pace, Inc. Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241009 — PeriCALM Patterns 3.0 | Perigen, Inc. Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |