Applied Medical Resources Corp. - FDA 510(k) Cleared Devices
Recent clearances: Voyant® Open Fusion Device (EB240/Open Fusion), Kii Structural Balloon Access System, GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device
45
Total
45
Cleared
0
Denied
FDA 510(k) Regulatory Record - Applied Medical Resources Corp. General & Plastic Surgery ✕
28 devices
Cleared
Nov 04, 2025
Voyant® Open Fusion Device (EB240/Open Fusion)
General & Plastic Surgery
68d
Cleared
Oct 31, 2025
Kii Structural Balloon Access System
General & Plastic Surgery
88d
Cleared
Jun 05, 2020
Voyant Open Fusion Device
General & Plastic Surgery
31d
Cleared
Apr 08, 2020
Voyant Maryland Fusion Device
General & Plastic Surgery
30d
Cleared
Dec 20, 2019
Voyant 5mm Fusion Device, Voyant Maryland Fusion Device
General & Plastic Surgery
23d
Cleared
Nov 14, 2018
Voyant Maryland Fusion Device
General & Plastic Surgery
50d
Cleared
Oct 11, 2018
Voyant Electrosurgical Generator
General & Plastic Surgery
52d
Cleared
Aug 30, 2018
Dissecting Balloon System
General & Plastic Surgery
31d
Cleared
Jan 24, 2014
EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK...
General & Plastic Surgery
184d
Cleared
Feb 08, 2013
ALEXIS O WOUND PROTECTOR/RETRACTOR
General & Plastic Surgery
462d
Cleared
Nov 16, 2010
LAPAROSCOPIC DISSECTOR
General & Plastic Surgery
11d
Cleared
Apr 02, 2010
ALEXIS ORTHOPAEDIC WOUND RETRACTOR
General & Plastic Surgery
77d