510(k) Clearances — Page 115
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K242343 — BPS Wrist Fracture System | Orthonovis, Inc. Fri Oct 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241434 — Video Ureteroscope System | Hunan Vathin Medical Instrument Co., Ltd. Fri Oct 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242325 — GripTract-GI Endoscopic Tissue Manipulator Lower GI Models | Actuated Medical, Inc. Fri Oct 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241746 — UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE; UMED REPROCESSED AIRCAST ELITE CALF CUFF 3040 3050; UMED REPROCESSED CTC VP 501 CALF CUFF; UMED REPROCESSED CTC VP 520 FOOT CUFF | United Medical Resources, LLC Fri Oct 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240376 — Electroporation System (N3000) | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Fri Oct 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241869 — BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve Toxismart Reader | Vivachek Biotech (Hangzhou) Co., Ltd. Fri Oct 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242364 — IdentiTi II Interbody System | Alphatec Spine, Inc. Fri Oct 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242671 — Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. Fri Oct 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242652 — Lunit INSIGHT DBT v1.1 | Lunit, Inc. Fri Oct 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241245 — EchoSolv AS | Echo IQ, Ltd. Fri Oct 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240074 — Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2) | Shenzhen Besdata Technology Co., Ltd. Fri Oct 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241977 — Injectable Root Canal Bioceramic Sealer (i-MTA SP) | Longly Biotechnology (Wuhan) Co., Ltd. Thu Oct 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241472 — Icona Hip Stem | Corin U.S.A. Limited Thu Oct 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242507 — OBSIDIO Conformable Embolic | Boston Scientific Thu Oct 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240393 — Exactech® TRULIANT® Knee System | Exactech, Inc. Thu Oct 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242660 — Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets | Zevex, Inc. Thu Oct 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233497 — Rest Assure System | Somnomed, Inc. Thu Oct 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240808 — Pulse Oximeter (WS20A) | Hunan Accurate Bio-Medical Technology Co., Ltd. Thu Oct 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240586 — Additive Manufacturing Zirconia Customized Restoration | Hangzhou Thales Medtech Co., Ltd. Thu Oct 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242616 — Lantern® Hip | Orthalign, Inc. Thu Oct 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241487 — Interwedge® Standalone Lateral | Foundation Surgical Group, Inc. Wed Oct 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241907 — Anovo Surgical System (model 6N) | Momentis Surgical , Ltd. Wed Oct 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241097 — Arthrex Virtual Implant Positioning (VIP) System Software | Arthrex, Inc. Wed Oct 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241925 — VitruvianScan (v1.0) | Perspectum, Ltd. Wed Oct 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242302 — RejuvaKnee Collagen Meniscus Implant | Collagen Matrix, Inc. Wed Oct 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240889 — ARTFX Lumbar PEEK Cages | Artfx Medical Wed Oct 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242005 — Versana Premier; Versana Premier Lotus; LOGIQ F | GE Medical Systems Ultrasound and Primary Care Diagnostics Wed Oct 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241561 — MammoScreen BD | Therapixel Wed Oct 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242377 — REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component | Osteoremedies, LLC Wed Oct 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240529 — 8F Modified Sheath System | Route 92 Medical, Inc. Wed Oct 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242613 — NxTAG® Respiratory Pathogen Panel | Luminex Molecular Diagnostics, Inc. Wed Oct 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240153 — Ceramic Etchant (HF-5 and HF-9) | Liaoning Upcera Co., Ltd. Wed Oct 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242651 — GM85 | Samsung Electronics Co., Ltd. Tue Oct 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240917 — Esperance 3+ Aspiration Catheter System | Wallaby Medical Tue Oct 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242678 — Definium Pace Select ET | Ge Hualun Medical Systems Co. , Ltd. Tue Oct 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242277 — Crown HT | Sprintray, Inc. Tue Oct 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241967 — The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml. | Thermo Fisher Scientific Tue Oct 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241331 — MuscleView | Springbok, Inc. Tue Oct 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240943 — LungVision | Bodyvision Medical , Ltd. Tue Oct 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241285 — Disposable Endoscope Valves Set (AF series) | Alton (Shanghai) Medical Instruments Co., Ltd. Tue Oct 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242498 — Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC | Aicheck Biotech, Inc. Tue Oct 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240331 — Electric wheelchair (YHWL002, YHWL003) | Yongkang Youha Electric Appliance Co., Ltd. Tue Oct 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241317 — Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) | Guangzhou Wondfo Biotech Co., Ltd. Mon Sep 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241657 — MSFX MIKRON SPINAL FIXATION SYSTEM | Mikron Makina Sanayi VE Ticaret Ltd. Sti. Mon Sep 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241151 — LUXEN 5G | Dentalmax Co., Ltd. Mon Sep 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN230011 — OcuCool | Recensmedical, Inc. Mon Sep 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241952 — AQUABEAM Robotic System (AB2000) | Procept Biorobotics Mon Sep 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242154 — Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. Mon Sep 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241836 — Kem Medical Lead-free Chemical Indicators for Steam Sterilization | Kem Medical Products Corporation Mon Sep 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242276 — CrossFAST Integrated Microcatheter Guide Extension System (CFM55) | Vantis Vascular, Inc. Mon Sep 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |