Applied Medical Resources Corp

FDA Regulatory Profile

Summary

Total Recalls
30 (3 Class I)
510(k) Clearances
103
Inspections
5
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1010-2026Class IIKii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23December 11, 2025
Z-1389-2024Class IIEpix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit Reference NumbeJanuary 30, 2024
Z-1388-2024Class IIEpix Universal Clip Applier, REF: CA500, STERILEEOJanuary 30, 2024
Z-2160-2020Class IIDR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620March 17, 2020
Z-2159-2020Class IIEpix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)006079151101March 17, 2020
Z-2161-2020Class IIClip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10)March 17, 2020
Z-2158-2020Class IIEpix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110March 17, 2020
Z-2034-2020Class IISTEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 - Product Usage: The deJanuary 31, 2020
Z-2035-2020Class IISTEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - Product Usage: The deJanuary 31, 2020
Z-2036-2020Class IISTEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - Product Usage: The deJanuary 31, 2020
Z-2037-2020Class IISTEALTH SPRING CLIP 6mm latis (1/4 Force). Non-Sterile, REF/UDI::A1702/(01)10607915110649 - Product January 31, 2020
Z-1847-2020Class IBard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R; CE0380DOctober 24, 2019
Z-1848-2020Class IApplied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cmOctober 24, 2019
Z-1846-2020Class IPython Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)October 24, 2019
Z-1959-2019Class IIKii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: 1330981, Exp: July 15, January 28, 2019
Z-0510-2020Class IIGelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.December 12, 2018
Z-0509-2020Class IIEpix Electrosurgical Probes with Smoke Evacuation, Angled L-Hook Tip, 5mm x 42 cm REF CW002 QTY: 1December 12, 2018
Z-2533-2017Class IIKii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-ThrMay 4, 2017
Z-1621-2016Class IIDirect Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscApril 1, 2016
Z-1330-2016Class IISTD GK258, AME Standard Kit 44 Product Usage: The Epix disposable laparoscopic clip applier is December 22, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K252740Voyant® Open Fusion Device (EB240/Open Fusion)November 4, 2025
K252442Kii Structural Balloon Access SystemOctober 31, 2025
K243152GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceOctober 2, 2025
K200021Applied Medical AnoscopeJanuary 6, 2021
K201212Voyant Open Fusion DeviceJune 5, 2020
K200598Voyant Maryland Fusion DeviceApril 8, 2020
K193292Voyant 5mm Fusion Device, Voyant Maryland Fusion DeviceDecember 20, 2019
K191294Transvaginal Access PlatformSeptember 6, 2019
K182653Voyant Maryland Fusion DeviceNovember 14, 2018
K182244Voyant Electrosurgical GeneratorOctober 11, 2018
K182024Dissecting Balloon SystemAugust 30, 2018
K171701GelPOINT Path Transanal Access PlatformJuly 20, 2017
K162676Voyant Open Fusion DeviceDecember 1, 2016
K153017Voyant Fine FusionJuly 6, 2016
K153288Voyant Open Fusion DeviceJune 1, 2016
K151480Epix Electrosurgical Probe with Smoke EvacuationFebruary 19, 2016
K143308GelPOINT Transvaginal Access PlatformOctober 13, 2015
K143536Voyant Fine Fusion DeviceApril 16, 2015
K143517Voyant Open Sealer-Divider DeviceMarch 27, 2015
K142427TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25December 23, 2014