510(k) Clearances — Page 77
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K250328 — UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program | Canon Medical Systems Corporation Wed Apr 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250907 — Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set | Sol-Millennium Medical, Inc. Wed Apr 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250274 — ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) | Biomerieux S.A. Wed Apr 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250282 — Persona C HR | A.T.S. Applicazione Tecnologie Speciali S.R.L. Wed Apr 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250683 — Resolve Fundus Camera | Optain Health, Inc. Wed Apr 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243541 — LumiRex Bronchoscope | Contra Healthcare Solutions, LLC Wed Apr 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244000 — Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+); | Shenzhen AOJ Medical Technology Co., Ltd. Wed Apr 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243934 — Stable-L Lumbar Interbody System | Nexus Spine, LLC Wed Apr 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251024 — TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge | Haemonetics Wed Apr 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243942 — Arctic Sun Stat Temperature Management System | Medivance, Inc. Wed Apr 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242354 — AllNEB | Enchant Tek Co. , Ltd. Tue Apr 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250069 — Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein | Comfort Rubber Gloves Industries Sdn. Bhd. Tue Apr 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250617 — Apex Flex | Sprintray, Inc. Tue Apr 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242255 — Qitexio® 4-Way Stopcock (QIT014) | Medex Tue Apr 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243963 — Pediatric Plating Platform Hip | OrthoPediatrics Corp. Tue Apr 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250308 — Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S) | Dongguan Boyuan Intelligent Technology Co.,Ltd Tue Apr 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243886 — ExpressCore Biopsy Device | Inrad, Inc. Tue Apr 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250962 — APRO 55 Intermediate Catheter | Alembic, LLC Tue Apr 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242495 — LMA Fastrach ETT SU | Teleflex Medical Tue Apr 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242211 — PUMA-G Pediatric System | Coaptech, Inc. Tue Apr 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250977 — Suture-TOOL System | Suturion AB Mon Apr 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242951 — Diode laser hair removal machine (QDTM-02) | Beijing Nubway S&T Co., Ltd. Mon Apr 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250256 — Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000)) | Aventamed Dac Mon Apr 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243532 — LumiRex Ureteroscope | Contra Healthcare Solutions, LLC Mon Apr 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241663 — Eminent Spine 3D Titanium Pedicle Screw System | Eminent Spine Mon Apr 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243896 — LenSx Laser System (8065998162) | Alcon Laboratories, Inc. Mon Apr 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250958 — APRO 55 Swift Catheter and Alembic Aspiration Tubing | Alembic, LLC Mon Apr 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243376 — uAngio AVIVA CX | Shanghai United Imaging Healthcare Co., Ltd. Mon Apr 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250030 — Flash Ultrasound System 5100 Point of Care | Philips Ultrasound, LLC Mon Apr 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250158 — Electric Wheelchair (ZH-W001,ZH-W002 ,ZH-W003) | Zhe Jiang Cleisman Industry and Trade Co.,Ltd Mon Apr 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251101 — AIRO Suction Unit (AIRO-01) | Cro, LLC Sat Apr 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243400 — cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test | Roche Molecular Systems, Inc. Fri Apr 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243876 — VERIFY STEAM Integrating Indicator | STERIS Corporation Fri Apr 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243406 — cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test | Roche Molecular Systems, Inc. Fri Apr 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251117 — Cervical Spine Truss System (CSTS) | 4Web Medical Fri Apr 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243821 — i-Cut | A.M.I. Agency For Medical Innovations GmbH Fri Apr 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251075 — DYNAMIS Implant System | Promethean Restorative, LLC Fri Apr 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250909 — Prelude Wave Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. Fri Apr 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243041 — contact forte Alpha | Bhm-Tech Produktionsgesellschaft Mbh Fri Apr 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243721 — Self Sealing Sterilization Pouches | Wellmed Dental Medical Supply Co., Ltd. Fri Apr 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243855 — BD Alaris Infusion System with Guardrails Suite MX | Carefusion 303, Inc. Fri Apr 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243998 — DCX Disposable Cassette (DCX) | Institut Geroges Lopez Fri Apr 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243082 — Infrared Thermometer | Guangzhou Daxin Health Technology Co., Ltd. Fri Apr 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250426 — Amulet Steerable Delivery Sheath | ABBOTT MEDICAL Fri Apr 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250289 — Intracavitary/Interstitial System | Varian Medical Systems Fri Apr 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244026 — PAL 7020 Console | Microaire Surgical Instruments, LLC Fri Apr 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243264 — DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) | Sorin Group Italia S.R.L. Fri Apr 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242321 — Kosmos | EchoNous, Inc. Fri Apr 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250608 — Mako Total Knee Application (3.0); Hybrid Tip Pointer | Mako Surgical Corp. Fri Apr 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250046 — Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) | Shenzhen Urion Technology Co., Ltd. Fri Apr 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |