510(k) Clearances — Page 93
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K244025 — Argo Knotless GENESYS Anchor | Conmed Corporation Tue Jan 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243423 — LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB) | Shenzhen Rainbow Technology Co., Ltd. Tue Jan 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243374 — HemosIL CL HIT-IgG(PF4-H) | Instrumentation Laboratory (IL) Co. Tue Jan 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243439 — Medical Monitor (27HS714S) | Lg Electronics.Inc Tue Jan 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244027 — SANSA HSAT | Huxley Medical Tue Jan 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231297 — Firstar Dental Unit | Firstar Dental Company Mon Jan 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243229 — Bunkerhill AVC | BunkerHill Health Mon Jan 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242941 — CO2 Laser Therapy Systems (SHE-LSP003-1) | Beijing Sano Laser S&T Development Co.,Ltd Mon Jan 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241266 — Imaging system of positron emission and X-ray computed tomography (DigitMI 930) | Raysolution Healthcare Co., Ltd. Mon Jan 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250014 — Symani Surgical System (820-03830) | Medical Microinstruments, Inc. Mon Jan 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243739 — AxCess® Expandable Interbody System | Elliquence, LLC Fri Jan 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243657 — ClearPoint System (Software Version 3.0) | ClearPoint Neuro, Inc. Fri Jan 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242322 — Bone Marrow Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. Fri Jan 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K244023 — MAGENTIQ-COLO (ME-APDS) | Magentiq Eye, Ltd. Fri Jan 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241239 — OrganProtex HTK Solution | Bridge TO Life, Ltd. Fri Jan 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241793 — Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. Fri Jan 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241057 — Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) | Wuhan Guangdun Technology Co.,Ltd.. Fri Jan 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241232 — Galen Second Read | Ibex Medical Analytics , Ltd. Fri Jan 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241107 — Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9) | Indiba S. A. U. Fri Jan 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241220 — Tina-quant Lipoprotein(a) Gen.2 Molarity | Roche Diagnostics Operations Fri Jan 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241199 — Rotatable Connector (5944RL) | Shenzhen Launch Electrical Co., Ltd. Thu Jan 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243158 — TeraRecon Aorta.CT (1.1.0) | Terarecon,Inc. Thu Jan 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241728 — Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050 | Murata Vios, Inc. Thu Jan 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243219 — MONARCH Platform (MON-000008) | Auris Health, Inc. Thu Jan 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241367 — RF Cannula | Shanghai Samedical & Plastic Instruments Co., Ltd. Thu Jan 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241234 — OTS 25-L (100-5) | Ots Medical , Ltd. Thu Jan 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243668 — ProLift Pivot Expandable Spacer System | Life Spine, Inc. Thu Jan 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242714 — Mobility Scooter (S-01); Mobility Scooter (S-02) | Zhejiang Seedream Medical Equipment Co., Ltd. Thu Jan 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243624 — Acu-Sinch Knotless Mini | Acumed, LLC Thu Jan 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241819 — CephNinja | Cyncronus, LLC Thu Jan 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242835 — Suture-TOOL System | Suturion AB Wed Jan 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243982 — Nicolet EDX | Natus Neurology Incorporated Wed Jan 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241956 — Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2) | Hunan Endoso Life Technology Co., Ltd. Wed Jan 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243977 — EMPHASYS Acetabular System | Depuy Ireland UC Wed Jan 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241357 — XT3 System | Biodynamik, Inc. Wed Jan 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243008 — Arthrex NanoScope System | Arthrex, Inc. Wed Jan 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242446 — Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | Persyst Development Corporation Wed Jan 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240311 — JETT Medical II | Compex, Spol, S.R.O. Wed Jan 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243139 — Reverso Pro System | Indiba S. A. U. Wed Jan 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243350 — Rapid Neuro3D | Ischemaview, Inc. Wed Jan 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243985 — Rio Drug Reconstitution Transfer Device | Icu Medical, Inc. Wed Jan 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243976 — ZeroClear Bag Access (423100) | Epic Medical Pte. , Ltd. Wed Jan 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243303 — Ziehm Vision RFD 3D | Ziehm Imaging GmbH Tue Jan 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242288 — Advanced Cryo Wart Remover | Medical Brands Laboratories B.V. Tue Jan 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243955 — Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. Tue Jan 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241443 — Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118) | Hathor Professional Skincare , Ltd. Tue Jan 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243929 — Oligio X | Wontech Co., Ltd. Tue Jan 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241444 — Biliary Pancreaticobiliary Scope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. Tue Jan 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241910 — Neonav ECG Tip Location System | Navi Medical Technologies Sun Jan 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243502 — EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3) | Olympus Medical Systems Corporation Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |