510(k) Clearances — Page 96
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K241113 — VIVIX-M | Vieworks Co., Ltd. Thu Jan 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244048 — Medi Lift Mask | Ya-Man, Ltd. Thu Jan 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233770 — Pepper EMS Training System | Pepper Interactive, Inc. Thu Jan 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242522 — Second Opinion CC | Pearl, Inc. Thu Jan 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243256 — WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B AntigenTest | Wondfo USA Co, Ltd. Thu Jan 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242715 — Pearl Clear Aligner | Pearl Digital, Inc. Thu Jan 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242416 — Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL | Hunan Vathin Medical Instrument Co., Ltd. Thu Jan 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243289 — ADDNOX (BPSPM1) | Nu Eyne Co., Ltd. Thu Jan 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240197 — cobas® liat CT/NG/MG nucleic acid test | Roche Molecular Systems, Inc. Thu Jan 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242834 — System 9 Sterile Battery Container | Stryker Instruments Thu Jan 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243885 — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid | Biofire Diagnostics, LLC Thu Jan 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241176 — Alere NT-proBNP for Alinity i Reagent Kit | Axis-Shield Diagnostics, Ltd. Thu Jan 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243848 — Cala kIQ | Cala Health, Inc. Thu Jan 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242936 — Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Sunray Medical Products, Inc. Wed Jan 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242109 — Xpert® Xpress CoV-2 plus (XPRS-COV2-10) | Cepheid® Wed Jan 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243860 — AtriClip PRO-Mini LAA Exclusion System (PROM) | AtriCure, Inc. Wed Jan 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241512 — Electrode Pad | Shenzhen Deliduo Medical Technology Co.,Ltd Wed Jan 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242229 — Micro Ace Gold Advanced Micro Access System | Merit Medical Systems, Inc. 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) |
| K242935 — Respiration Data Management Software (PAP Link PC) | BMC Medical Co., Ltd. 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) |
| K243452 — Orthoscan VERSA Mini C-Arm | Ziehm-Orthoscan, Inc. 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) |
| 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) |
| K243791 — Air Pressure Therapy System | Xiamen Weiyou Intelligent Technology Co., Ltd. Mon Jan 13 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) |
| 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) |
| K243527 — High Flow Insufflation Unit (UHI-4) | Olympus Medical Systems Corporation 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) |
| K243950 — ARVIS® Shoulder | Kico Knee Innovation Company Pty, Ltd. Mon Jan 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |