510(k) Clearances — Page 80
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,388 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K243852 — Elfor-L | Elfi-Tech , Ltd. Mon Apr 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243558 — Canvas Dx | Cognoa, Inc. Fri Apr 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN240064 — CT-132 | Click Therapeutics, Inc. Fri Apr 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243898 — Chlorine Sentinel II | Nelson Environmental Technologies, Inc. Fri Apr 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250416 — GBrain MRI | Galileo Cds, Inc. Fri Apr 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243710 — Disposable ureteral access sheath | Shenzhen Trious Medical Technology Co., Ltd. Fri Apr 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250811 — Dental Zirconia Ceramic | Aidite (Qinhuangdao) Technology Co., Ltd. Fri Apr 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243044 — Alma Harmony | Alma Lasers, Inc. Fri Apr 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242098 — Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2) | Shenzhen Vivolight Medical Device & Technology Co., Ltd. Fri Apr 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243921 — LED Curing Lights (DB686 HALO) | Foshan Coxo Medical Instrument Co., Ltd. Fri Apr 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243260 — FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R | Fujifilm Corporation Fri Apr 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243346 — cobas liat SARS-CoV-2 v2 nucleic acid test | Roche Molecular Systems, Inc. Fri Apr 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243537 — XeliteMed VertehighFix High Viscosity Spinal Bone Cement System | Xelite Biomed , Ltd. Fri Apr 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250748 — KLAXON (TWIST); KLAXON (TWIST R) | Klaxon-Mobility GmbH Fri Apr 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242646 — Dental Implant Unit | Guilin Aesthedent Medical Instruments Co., Ltd. Fri Apr 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250081 — Atlantis® Abutments in Titanium | Dentsply Sirona Fri Apr 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243888 — Medline UNITE® REFLEX® Hybrid Nitinol Implant System | Medline Industries, LP Fri Apr 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242748 — Oncospace | Oncospace, Inc. Fri Apr 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242120 — OTOPLAN | Cascination AG Fri Apr 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243356 — Asiga DentaBASE | Asiga Pty, Ltd. Fri Apr 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242772 — AirSurgN Insufflator (10030/AirSurgN) | SmartsurgN, Inc. Fri Apr 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250438 — CooperSurgical Milex® Pessaries | CooperSurgical, Inc. Fri Apr 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242600 — Second Opinion Periapical Radiolucency Contours | Pearl, Inc. Fri Apr 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243857 — Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) | Shanghai AnQing Medical Instrument Co., Ltd. Fri Apr 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250177 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC Thu Apr 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243953 — Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) | Vizionfocus, Inc. Thu Apr 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243145 — syngo.CT LVO Detection | Siemens Medical Solutions USA, Inc. Thu Apr 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250371 — cryoICE cryoXT cryoablation probe (cryoXT) | AtriCure, Inc. Thu Apr 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250389 — XNY Disposable Gastric Calibration Tube | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd Thu Apr 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250009 — LED Curing Light (C01-X, C02-X) | Premium Plus (Dongguan) Limited Thu Apr 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250754 — cmAngio® (V1.6) | Curemetrix, Inc. Thu Apr 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250058 — NEAT 001 | Brain Electrophysiology Laboratory Company, LLC Thu Apr 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250112 — FitboneTM Trochanteric | Orthofix Srl Thu Apr 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243943 — TriMed® Compression Screws | TriMed, Inc. Thu Apr 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242045 — Initia T3 Acetabular Hemispherical Shell System | Kyocera Medical Technologies, Inc. Thu Apr 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243240 — Vitrea CT VScore | Canon Medical Informatics, Inc. Thu Apr 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242561 — Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) | Donnevie Medical Technology (Shanghai) Co. , Ltd. Thu Apr 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242928 — Tesera-k SC System | Kyocera Medical Technologies, Inc. Thu Apr 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250486 — Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) Thu Apr 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242089 — Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) | Jiangsu Ruifuda Medical Device Co., Ltd. Thu Apr 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250098 — Bard Soft Mesh; Bard Soft Mesh Pre-Shaped | Davol, Inc. Wed Apr 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243214 — Dexcom G7 15 Day Continuous Glucose Monitoring System | Dexcom, Inc. Wed Apr 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K250373 — ProLift Expandable Spacer System | Life Spine, Inc. Wed Apr 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN240021 — Tango® Belt (Model SAS-001-01 (XS); Model SAS-001-02 (S); Model SAS-001-03 (M); Model SAS-001-04 (L); Model SAS-001-05 (XL)) | Active Protective Technologies, Inc. Wed Apr 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241589 — Ceribell Seizure Detection Software | Ceribell, Inc. Wed Apr 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243613 — Patch-TEA (Model TRI-21) | Transtimulation Research, Inc. Wed Apr 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243743 — autoSCORE (V 2.0.0) | Holberg Eeg AS Wed Apr 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242429 — CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System | Becton Dickinson Inc. (Bd) Wed Apr 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243819 — Luminopia | Luminopia, Inc. Wed Apr 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243966 — FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) | Faceheart Corp. Wed Apr 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |