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Applied Medical Resources Corp.

FDA 510(k) & PMA Approved Devices — 43 products

Total Devices43
Categories0
Latest FDA decision
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
510(k) K113268 ALEXIS O WOUND PROTECTOR/RETRACTORKGW2013-02-08 View
510(k) K110792 GELPOINT PATHFER2011-05-23 View
510(k) K103282 LAPAROSCOPIC DISSECTORGEI2010-11-16 View
510(k) K100120 ALEXIS ORTHOPAEDIC WOUND RETRACTORKGW2010-04-02 View
510(k) K093296 ALEXIS LAPAROSCOPIC SYSTEMKGW2009-11-05 View
510(k) K090275 GELPORT SINGLE INCISION ACCESS SYSTEMGCJ2009-02-18 View
510(k) K083638 FIXATION TROCARSGCJ2008-12-23 View
510(k) K072674 KII TROCAR SYSTEMGCJ2007-10-05 View
510(k) K063658 INTRAVASCULAR INTRODUCER SYSTEMDYB2007-09-12 View
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