510(k) Clearances — Page 57
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K250036 — MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) | Beckman Coulter, Inc. Fri Aug 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250397 — Helios Dermal Scaffold | Helios Biomedical, Inc. Fri Aug 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251877 — JMS CAVEO A.V. Fistula Needle Set | JMS North America Corporation Fri Aug 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252259 — AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup | Assure Tech., LLC Fri Aug 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250867 — Dunamis Screw and Suture Locking System | Dunamis Medical, LLC Fri Aug 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251062 — Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack | Geistlich Pharma AG Thu Aug 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243544 — BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini | Biofire Diagnostics, LLC Thu Aug 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250164 — Cassette Autoclave (ACA5) | Guangzhou Ajax Medical Equipment Co., Ltd. Thu Aug 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250916 — WinForth (LM-E470KA) | Shenzhen Leaflife Technology Co., Ltd. Thu Aug 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251176 — IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C) | Shenzhen Mlay Intelligent Technology Co., , Ltd. Thu Aug 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250898 — Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm) | Stryker Sustainability Solutions Thu Aug 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251526 — FilmArray GI Control Panel M238 | Maine Molecular Quality Controls, Inc. Thu Aug 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243437 — mOm Essential Incubator (ME1) | Mom Incubators Limited Thu Aug 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243905 — Stitch Cerclage Suture Tapes | GM Dos Reis Industria e Comercio Ltda. Thu Aug 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243600 — 3nethra neo HD FA; 3nethra neo HD | Forus Health Pvt.Ltd Thu Aug 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251012 — TRUDERMAL Pro (ZLD-390) | Shenzhen Kaiyan Medical Equipment Co., Ltd. Thu Aug 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243579 — AeroJet Ventilation Catheter | Pipeline Medical Products, LLC Wed Aug 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251569 — Bone Screw | Osstem Implant Co., Ltd. Wed Aug 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250931 — Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121) | Unimed Medical Supplies, Inc. Wed Aug 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252192 — Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25) | Huizhou Lvb Maternal and Infant Supplies Co., Ltd. Wed Aug 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243279 — DOLORCLAST Focused Shock Waves | E.M.S Electro Medical Systems S.A Wed Aug 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251046 — S.I.N. Dental Implant System | S.I.N. Implant System Ltda Wed Aug 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251495 — MBT Compass HT CA Software; MBT FAST Shuttle US IVD | Bruker Daltonics GmbH & Co. KG Wed Aug 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250163 — T2 Alpha Femur Retrograde Nailing System | Stryker GmbH Wed Aug 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252201 — HS Fiber | Riverpoint Medical Wed Aug 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243653 — KARL STORZ HOPKINS Telescopes for Urology | Karl Storz SE & CO. KG Wed Aug 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252226 — Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) | Nuwellis, Inc. Wed Aug 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251519 — RelieVRx (Pico G3) | Appliedvr Wed Aug 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250841 — Electrotherapy Electrodes | Baisheng Medical Co., Ltd. Wed Aug 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251033 — Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons | Unibeauty (Hubei) Technology Co., Ltd. Wed Aug 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250836 — 14F Duo-Flow® Side X Side Double Lumen Catheter | Medical Components, Inc. Tue Aug 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243562 — CuffGuard | Idmed Tue Aug 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251494 — Eko Foundation Analysis Software with Transformers (EFAST) | Eko Health, Inc. Tue Aug 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252083 — HOTWIRE System RF Generator and Footswitch (optional accessory) | Atraverse Medical, Inc. Tue Aug 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250755 — DS Core Diagnosis | Dentsply Sirona, Inc. Tue Aug 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250294 — Straumann® RidgeFit Implants | Institut Straumann AG Tue Aug 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251879 — Sulopenem SPM 2 µg | Liofilchem Tue Aug 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251098 — Identity Revision Humeral Stems | Zimmer, Inc. Mon Aug 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251245 — OxyMinder Pro (10310) | Bio-Med Device, Inc. Mon Aug 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251823 — UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes (EBS-500C); UE BRONCHO Single-Use Bronchoscopes (EBS-600C); UE Display (UE-M10S) | Zhejiang UE Medical Corp. Mon Aug 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251862 — External Fixation Bone Distractor | Paragon 28, Inc. Mon Aug 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241731 — Outlook Surgical Versa One System (8900139) | Resnent, LLC Mon Aug 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251125 — MagVenture TMS Therapy System | Tonica Elektronik A/S Mon Aug 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251327 — XERF | Lutronic Corporation Mon Aug 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232456 — RW-1 | Mediott, Inc. Mon Aug 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K251873 — Saige-Dx | DeepHealth, Inc. Mon Aug 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250462 — UL UHD-Clear View 4K Camera System (UL-3Chip 4K) | Univlabs Technologies Private Limited Mon Aug 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252211 — Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH) | Cnc Technologies Mon Aug 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250207 — eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) | Anker Innovations Limited Mon Aug 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K252170 — OptiVu Shoulder | Mr Surgical Solutions, LLC Fri Aug 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |