510(k) Clearances — Page 132
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K233354 — WVSM Pro (Series) (500-0030-XX) | Athena Gtx, Inc. Wed Jun 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234059 — Forma Medical Optimal Plating System | Forma Medical, Inc. Wed Jun 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233413 — Ultraphon Chemical Indicator (TRO-T and TRO-B) | True Indicating, LLC Wed Jun 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241507 — ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK) | Aln S.A.R.L. Wed Jun 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240875 — Unity Knee PS-C Tibial Insert | Corin U.S.A. Limited Wed Jun 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233006 — MyndMove, MyndMove 2.0 | Myndtec, Inc. Tue Jun 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233368 — Allograft Delivery Device (OFAC-C) | Bioventus, LLC Tue Jun 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232640 — Venowave VW5 | Thermabright Tue Jun 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240824 — Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005) | Ningxia Qiaoen Medical Technology Co., Ltd. Tue Jun 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232111 — NeoBeat, NeoBeat Mini | Laerdal Medical AS Tue Jun 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240582 — VEA Align; spineEOS | Eos Imaging Tue Jun 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241158 — ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3 | Asahi Intecc Co., Ltd. Tue Jun 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241035 — PMT Posterior Cervical Stabilization System (PCSS) | Providence Medical Technology, Inc. Tue Jun 25 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241120 — Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S) | Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd. Mon Jun 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233630 — Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aBox 2 | Ambu A/S Mon Jun 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240259 — APEX 3D Total Ankle Replacement System | Paragon 28, Inc. Mon Jun 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233123 — SILKRO | Hironic Co., Ltd. Mon Jun 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241144 — Picosecond Nd:YAG Laser (PICOCAREMAJESTY) | Wontech Co., Ltd. Mon Jun 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233204 — Philips IntelliSite Pathology Solution 5.1 | Philips Medical Systems Nederland B.V. Mon Jun 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232952 — Copran Zri | Whitepeaks Dental Solutions GmbH Mon Jun 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233288 — NLZ Built-In Motor System | Nakanishi, Inc. Mon Jun 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233196 — Medihub Prostate | JLK, Inc. Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240862 — Medicom Sterilization Wrap | Medicom Group, Inc. Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234095 — OtoNova/OtoNova Pro | Otodynamics Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233259 — Xerosyn | Xerothera, Inc. Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241476 — ToxiSeal Vial Adaptor with External Flip Balloon | Epic Medical Pte. , Ltd. Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241117 — M6-C Single Use, Disposable Instrumentation | Spinal Kinetics / Orthofix / Seaspine Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233240 — GERDX-System | G-Surg GmbH Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241442 — eZSURE Empty Fluid Container with ProSeal Injection Site | Epic Medical Pte. , Ltd. Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233096 — PRESSUREALERT® Pressure Monitoring System | Position Health, LLC Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241519 — Invictus® Small Stature Spinal Fixation System | Alphatec Spine, Inc. Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233326 — Merge Hemo, Model RCSV2 | Merge Healthcare Incorporated Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241459 — MOTUS PRO Family | El.En S.P.A. Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233885 — rainbow Paste Stain SE | Genoss Co., Ltd. Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240631 — V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240387 — MINAMO blue; MINAMO viola | Asahi Intecc Co., Ltd. Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232807 — Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) | Owens & Minor (O&M) Halyard, Inc. Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240663 — Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S) | Guangzhou Red Pine Medical Instrument Co., Ltd. Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233230 — See Factor CT3 | Epica International, Inc. Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240465 — O-arm O2 Imaging System | Medtronic Navigation, Inc. Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240643 — MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream | Guangzhou Decheng Biotechnology Co., Ltd. Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233549 — Tempus ECG-AF | Tempus AI, Inc. Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233280 — SteadyTemp | Steadysense GmbH Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233253 — eCARTv5 Clinical Deterioration Suite (eCART) | Agilemd, Inc. Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240649 — Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW) | Shenzhen Ulike Smart Electronics Co., Ltd. Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233876 — UNITY VCS (8065000296); UNITY CS (8065000297) | Alcon Laboratories, Inc. Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K234155 — Nimbl (model PD08-N1) | Tactile Medical Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240728 — CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test | CorDx, Inc. Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232975 — Pulse Oximeter (MD300C228) | Beijing Choice Electronic Technology Co., Ltd. Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233361 — Sunny Cup and Applicator | Menstrual Mates Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |