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Applied Medical Resources Corp.

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

Total Devices11
Categories4
Latest Approval2025-11-04
TypeNumberDevice NameCodeDate
510(k) K252740 Voyant® Open Fusion Device (EB240/Open Fusion) GEI 2025-11-04 View
510(k) K252442 Kii Structural Balloon Access System GCJ 2025-10-31 View
510(k) K243152 GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device HEW 2025-10-02 View
510(k) K201212 Voyant Open Fusion Device GEI 2020-06-05 View
510(k) K200598 Voyant Maryland Fusion Device GEI 2020-04-08 View
510(k) K193292 Voyant 5mm Fusion Device, Voyant Maryland Fusion Device GEI 2019-12-20 View
510(k) K191294 Transvaginal Access Platform HEW 2019-09-06 View
510(k) K182653 Voyant Maryland Fusion Device GEI 2018-11-14 View
510(k) K182244 Voyant Electrosurgical Generator GEI 2018-10-11 View
510(k) K182024 Dissecting Balloon System GCJ 2018-08-30 View
510(k) K171701 GelPOINT Path Transanal Access Platform FER 2017-07-20 View