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Applied Medical Resources Corporation

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12
Categories6
Latest FDA decision2026-04-24
TypeNumberDevice NameCodeDateActions
510(k) K260982 Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403)KGW2026-04-24 View
510(k) K253531 Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)KGW2026-02-23 View
510(k) K252412 Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)GEI2025-10-31 View
510(k) K232880 Inzii Ripstop Redeployable Retrieval SystemGCJ2023-11-01 View
510(k) K222284 Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)GEI2022-10-14 View
510(k) K220969 GelPOINT V-Path Vaginal Access SystemMOK2022-09-16 View
510(k) K211043 Alexis Contained Extraction SystemGCJ2022-03-31 View
510(k) K202049 Python Catheter/Over-the-Wire Latis Graft Cleaning CatheterDXE2021-09-07 View
510(k) K190331 Applied Medical Laparoscopic Linear CutterGDW2019-11-22 View
510(k) K180699 Voyant Open Fusion DeviceGEI2018-04-13 View
510(k) K172624 Voyant 5mm Fusion DeviceGEI2018-02-13 View
510(k) K171684 Epix Electrosurgical Probe with Smoke EvacuationGEI2017-08-07 View