510(k) Clearances — Page 161
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K230507 — Zimed Distal Medial Tibial Plate and Screw System | Zimed Medikal Thu Jan 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233556 — LED Eye mask (EY-20R, A20, EY-20N) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Thu Jan 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233671 — Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aView 2 Advance | Ambu A/S Thu Jan 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232136 — syngo.CT Applications | Siemens Medical Solutions USA, Inc. Thu Jan 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230277 — Pulse Oximeter(Model OHT60,OXH78) | Cofoe Medical Technology Co., Ltd. Thu Jan 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231033 — CEPTRE® Knotted UHMWPE Suture PEEK Anchor | Healthium Medtech Limited Thu Jan 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231058 — Hudson RCI® AddiPak® Unit Dose Vial | Medline Industries, LP Thu Jan 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223228 — Dayspring | Koya Medical, Inc. Thu Jan 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223397 — HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens | Hoya Lamphun , Ltd. Wed Jan 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233395 — Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) | Alliage S/A Industrias Médico Odontológica Wed Jan 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231707 — ResQ Administration Set | Q For Plastic Industries Wed Jan 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231779 — REMI AI Discrete Detection Module | Epitel, Inc. Wed Jan 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231256 — Carecube Negative Pressure Isolation Chamber | Carecubes, Inc. Wed Jan 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232589 — Horos MD | Icat Solutions, Ltd. Wed Jan 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233550 — MOSAIC 3D (Surgical Laser) | Lutronic Aesthetic Tue Jan 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233790 — ACL TOP 970 CL | Instrumentation Laboratory Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223714 — UniFit Dental Implant System | Adin Dental Implant Systems , Ltd. Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230986 — Bladder Scanner | Avantsonic Technology Co., Ltd. Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230438 — URIS Smart Path Implant System & Prosthetic | Truabutment, Inc. Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233362 — Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) | Pelvital USA, Inc. Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232688 — NQ TMS for MDD (NQv1-MU-01) | Neuroqore, Inc. Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233856 — Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal | Alcon Laboratories, Inc. Fri Dec 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230997 — EvoWalk 1.0 System | Evolution Devices, Inc. Thu Dec 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233405 — Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim | Eco Medi Glove Sdn. Bhd. Thu Dec 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230985 — Planmeca Viso | Planmeca Oy Thu Dec 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230006 — Ankyras | Mentice Spain S.L. Thu Dec 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230891 — SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant | Healthium Medtech Limited Thu Dec 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231055 — x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) | De Götzen S.R.L. Thu Dec 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233858 — TriSalus TriGuideTM Guiding Catheter | Trisalus Life Sciences Wed Dec 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232518 — EndoSound Vision System; EVS | Endosound, Inc. Wed Dec 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231914 — Nurochek-II System | Headsafe Mfg Pty, Ltd. Wed Dec 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232756 — Colibrí | Copan Wasp Srl Wed Dec 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231084 — TearCare MGX System | Sight Sciences, Inc. Wed Dec 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233300 — POWEReam 1/4 Drive | Stryker Instruments Tue Dec 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233515 — Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) | Nuwellis, Inc. Tue Dec 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232937 — BTL-899M | BTL Industries, Inc. Tue Dec 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231130 — TumorSight Viz | SimBioSys, Inc. Tue Dec 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233659 — Suture Wing | Osteonic Co., Ltd. Tue Dec 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231086 — CPM System | Analog Devices, Inc. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232293 — kallisio stentra oral stent | Kallisio, Inc. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232479 — ART-Plan | Therapanacea Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233058 — VivaChek Link Plus Blood Glucose Monitoring System | Vivachek Biotech (Hangzhou) Co., Ltd. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232789 — VIO System (V-1000) | Enspectra Health, Inc. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233082 — TopCEM Dual Cure Resin Cement | Rizhao Huge Biomaterials Company, Ltd. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232300 — ElastiMed SACS | Elastimed , Ltd. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231794 — Elegant Advanced CompHort | Viramal Limited Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233109 — TP Pivot Pro Needle Guide | Civco Medical Solutions Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230439 — WellCare Anoscope | Well Care (Wuhan) Medical Technology Co., Ltd. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233304 — Omnimax S3, Omnimax S4 | Sharplight Technologies, Ltd. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233205 — Distal Access Catheter | Shanghai Heartcare Medical Technology Co., Ltd. Fri Dec 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |