Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Applied Medical Resources Corp.

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories4
Latest FDA decision2025-11-04
TypeNumberDevice NameCodeDateActions
510(k) K252740 Voyant® Open Fusion Device (EB240/Open Fusion)GEI2025-11-04 View
510(k) K252442 Kii Structural Balloon Access SystemGCJ2025-10-31 View
510(k) K243152 GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceHEW2025-10-02 View
510(k) K201212 Voyant Open Fusion DeviceGEI2020-06-05 View
510(k) K200598 Voyant Maryland Fusion DeviceGEI2020-04-08 View
510(k) K193292 Voyant 5mm Fusion Device, Voyant Maryland Fusion DeviceGEI2019-12-20 View
510(k) K191294 Transvaginal Access PlatformHEW2019-09-06 View
510(k) K182653 Voyant Maryland Fusion DeviceGEI2018-11-14 View
510(k) K182244 Voyant Electrosurgical GeneratorGEI2018-10-11 View
510(k) K182024 Dissecting Balloon SystemGCJ2018-08-30 View
510(k) K171701 GelPOINT Path Transanal Access PlatformFER2017-07-20 View
↑