510(k) Clearances — Page 62
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K250949 — Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) | Olympus Medical Systems Corporation Wed Jul 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243782 — StimTrial Neuromodulation System | Bioventus, LLC Wed Jul 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251202 — da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. Wed Jul 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243412 — ARCHIMEDES Biodegradable Pancreatic Stent | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) Wed Jul 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243397 — uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. Wed Jul 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251845 — Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus | Kerecis Limited Wed Jul 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250181 — AV Viewer | Philips Medical Systems Nederland B.V. Tue Jul 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250350 — Thrive 2-in-1 Breast Pump (Model P3) | Shenzhen TPH Technology Co., Ltd. Tue Jul 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251045 — Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N) | Unimed Medical Supplies, Inc. Tue Jul 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250119 — Tempus ECG-Low EF | Tempus AI, Inc. Tue Jul 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242237 — Jewel Soft Tissue Reinforcement Device (102-6005) | Xiros Limited Tue Jul 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251053 — Shinetell PlusTM Digital Early Pregnancy Test | Hangzhou AllTest Biotech Co., Ltd. Tue Jul 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251844 — Kerecis SurgiBind (50241) | Kerecis Limited Tue Jul 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242818 — IsoSphere | Isoaid, LLC Tue Jul 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251554 — Materialise TKA Guide System | Materialise NV Mon Jul 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251850 — Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. Mon Jul 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250660 — LUMINOS Q.namix T; LUMINOS Q.namix R | Siemens Medical Solutions Mon Jul 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251173 — Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF) | Shenzhen Fansizhe Science and Technology Co., Ltd. Mon Jul 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251378 — CoolTone | Zimmer Medizinsysteme GmbH Mon Jul 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250120 — GECHO | Narnar, LLC Mon Jul 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250504 — Leonardo Duster | Ceramoptec GmbH Mon Jul 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251096 — PeekMed web | Peek Health, S.A. Mon Jul 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251132 — The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws | Acumed, LLC Mon Jul 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250185 — Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24) | Jiangxi Aicare Medical Technology Co., Ltd. Mon Jul 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243917 — F&P Optiflow Air/Oxygen Flow Source | Fisher & Paykel Healthcare, Ltd. Mon Jul 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251488 — FLOWRUNNER Aspiration System | Expanse Medical, Inc. Mon Jul 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243598 — Welch Allyn Connex® 360 (Multiple) | Welch Allyn, Inc. Sun Jul 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243199 — NightWatch+ US | Livassured BV Sat Jul 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251786 — Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® | Geistlich Pharma AG Fri Jul 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251134 — RipCord | TriMed, Inc. Fri Jul 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251482 — AEON Endoscopic Powered Stapler | Lexington Medical, Inc. Fri Jul 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251352 — Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration) | Codonics.Incorporated Fri Jul 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251808 — Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems | Philips Medical Systems Nederland B.V. Fri Jul 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251470 — ResiCem EX | Shofu Dental Corporation Fri Jul 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251436 — Resolve Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. Fri Jul 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250942 — Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK) | Shenzhen Ulike Smart Electronics Co., Ltd. Fri Jul 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250156 — Choice 2 DC | Bisco, Inc. Fri Jul 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251472 — Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System | Inion OY Fri Jul 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250772 — Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter | Surgical Instrument Service and Savings, Inc. Fri Jul 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243655 — TurbAlign | Spirair, Inc. Fri Jul 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250820 — Disposable Trocars | Sinolinks Medical Innovation, Inc. Fri Jul 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251149 — AviClear Laser System | Cutera, Inc. Fri Jul 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250034 — Natural rubber latex male condom | Shaoguan Regenex Pharmaceuticals Co., Ltd. Fri Jul 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250761 — KALA Therapy Wand (Model: KALA-03) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Fri Jul 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251155 — BD Cathena Safety IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. Fri Jul 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250266 — Ceragem Automatic Thermal Massager (CGM MB-2401) | Ceragem Co., Ltd. Fri Jul 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243227 — B-Scan | Accutome, Inc. Doing Business AS Keeler USA Fri Jul 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250762 — ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R) | Olympus Medical Systems Corporation Fri Jul 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241179 — Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) | VivaQuant, Inc. Fri Jul 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243274 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) | Centers for Disease Control and Prevention Fri Jul 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |