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Applied Medical Resources Corp

64 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23 recall (Z-1010-2026)Applied Medical Resources Corp2026-01-02
Epix Universal Clip Applier, REF: CA500, STERILEEO recall (Z-1388-2024)Applied Medical Resources Corp2024-03-27
Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit Refer recall (Z-1389-2024)Applied Medical Resources Corp2024-03-27
Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A recall (Z-1846-2020)Applied Medical Resources Corp2020-05-07
Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R; C recall (Z-1847-2020)Applied Medical Resources Corp2020-05-07
Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, recall (Z-1848-2020)Applied Medical Resources Corp2020-05-07
Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optic recall (Z-2533-2017)Applied Medical Resources Corp2017-06-14
Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels i recall (Z-1621-2016)Applied Medical Resources Corp2016-05-06
CA500 Epix Universal Clip Applier Product Usage: The Epix disposable laparoscopic clip app recall (Z-1329-2016)Applied Medical Resources Corp2016-04-05
STD GK258, AME Standard Kit 44 Product Usage: The Epix disposable laparoscopic clip applie recall (Z-1330-2016)Applied Medical Resources Corp2016-04-05
STD KIT GK213, AME Standard Kit 15 Product Usage: The Epix disposable laparoscopic clip ap recall (Z-1331-2016)Applied Medical Resources Corp2016-04-05
STD KIT GK260, Standard Set 360 Z Product Usage: The Epix disposable laparoscopic clip app recall (Z-1332-2016)Applied Medical Resources Corp2016-04-05
Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant Open recall (Z-2769-2015)Applied Medical Resources Corp2015-09-15
Applied Medical's Inzii 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Mod recall (Z-0183-2014)Applied Medical Resources Corp2014-01-24
Applied Medicals Epix and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C414 recall (Z-1521-2013)Applied Medical Resources Corp2013-06-07
Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thora recall (Z-0644-2013)Applied Medical Resources Corp2013-01-07
Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Numbers & Descrip recall (Z-2446-2012)Applied Medical Resources Corp2012-09-25
Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL recall (Z-2447-2012)Applied Medical Resources Corp2012-09-25
Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IRR-023-10F,CATHETE recall (Z-2448-2012)Applied Medical Resources Corp2012-09-25
Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R36 Prod recall (Z-3066-2011)Applied Medical Resources Corp2011-08-24
Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R37 Prod recall (Z-3067-2011)Applied Medical Resources Corp2011-08-24
Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R38 Prod recall (Z-3068-2011)Applied Medical Resources Corp2011-08-24
Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R39 Prod recall (Z-3069-2011)Applied Medical Resources Corp2011-08-24
Surgical Clamp Inserts, Model#G-8600, 86MM Insert Soft/Traction, 15/Bx Surgical Clamps and recall (Z-3004-2011)Applied Medical Resources Corp2011-08-11
Surgical Clamp Inserts, Model#G-8650, 86MM Insert Soft/Fibra 15/Bx Surgical Clamps and ins recall (Z-3005-2011)Applied Medical Resources Corp2011-08-11
Surgical Clamp Inserts, Model#G-8655, 86MM Insert Fibra/Fibra 15/Bx Surgical Clamps and in recall (Z-3006-2011)Applied Medical Resources Corp2011-08-11
Direct Drive Grasper, Model numbers C4130, 5MM X 35CM DIRECT DRIVE GRASPER 10/BX Intended recall (Z-2986-2011)Applied Medical Resources Corp2011-08-10
Direct Drive Grasper, Model number C4140, 5MM X 45CM DIRECT DRIVE GRASPER 10/BX Intended U recall (Z-2987-2011)Applied Medical Resources Corp2011-08-10
Direct Drive Grasper, VARIOUS KITS CONTAINING EITHER C4130 OR C4140 Intended Usage: The gr recall (Z-2988-2011)Applied Medical Resources Corp2011-08-10
Applied Medical's Direct Drive Laparoscopic Clip Applier; Model Number: CA090 The device i recall (Z-1499-2011)Applied Medical Resources Corp2011-03-03
Applied Medical's GELPOINT LAP CHOLE KIT 2; Model Number: CK102 The device is used to clos recall (Z-1500-2011)Applied Medical Resources Corp2011-03-03
Applied Medical's LAP CHOLE KIT 5 GK; Model Number: GK105 The device is used to close a cl recall (Z-1501-2011)Applied Medical Resources Corp2011-03-03
Applied Medical's LAP CHOLE KIT 7 GK; Model Number: GK107 The device is used to close a cl recall (Z-1502-2011)Applied Medical Resources Corp2011-03-03
Applied Medical's LAP CHOLE KIT 8 GK; Model Number: GK108 The device is used to close a cl recall (Z-1503-2011)Applied Medical Resources Corp2011-03-03
Applied Medical's LAP CHOLE KIT 9 GK; Model Number: GK109-H The device is used to close a recall (Z-1504-2011)Applied Medical Resources Corp2011-03-03
Applied Medical's LAP CHOLE KIT 16 GK; Model Number: GK116 The device is used to close a c recall (Z-1505-2011)Applied Medical Resources Corp2011-03-03
Applied Medical's LAP CHOLE KIT ; Model Number: K0491 The device is used to close a clip i recall (Z-1506-2011)Applied Medical Resources Corp2011-03-03
Applied Medical's LAP CHOLE KIT ; Model Number: K0492 The device is used to close a clip i recall (Z-1507-2011)Applied Medical Resources Corp2011-03-03
Applied Medical's AM CHOLE KIT-TAM1; Model Number: K0509 The device is used to close a cli recall (Z-1508-2011)Applied Medical Resources Corp2011-03-03
Applied Medical's LAP CHOLE KIT - 1A; Model Number: K0522 The device is used to close a cl recall (Z-1509-2011)Applied Medical Resources Corp2011-03-03
Applied Medical's LAP CHOLE KIT - BLADED; Model Number: K0552 The device is used to close recall (Z-1510-2011)Applied Medical Resources Corp2011-03-03
Applied Medical's LAP CHOLE KIT ; Model Number: K0630 The device is used to close a clip i recall (Z-1511-2011)Applied Medical Resources Corp2011-03-03
Applied Medical's LAP CHOLE KIT ; Model Number: K0684 The device is used to close a clip i recall (Z-1512-2011)Applied Medical Resources Corp2011-03-03
Applied Medical's LAP CHOLE KIT ; Model Number: K2114 The device is used to close a clip i recall (Z-1513-2011)Applied Medical Resources Corp2011-03-03
Applied Medical's PREMIUM DISPOSABLE LAP CHOLE KIT; Model Number: K2136 The device is used recall (Z-1514-2011)Applied Medical Resources Corp2011-03-03
Applied Medical's LAP CHOLE KIT; Model Number: K2154 The device is used to close a clip in recall (Z-1515-2011)Applied Medical Resources Corp2011-03-03
Applied Medical's LAP CHOLE ; Model Number: K2155 The device is used to close a clip in or recall (Z-1516-2011)Applied Medical Resources Corp2011-03-03
Applied Medical's KW/MOH LAP CHOLE KIT; Model Number: K2184 The device is used to close a recall (Z-1517-2011)Applied Medical Resources Corp2011-03-03
Applied Medical 15x100mm Kii Optical Access System, Non-Threaded 6/Box, Model Number: C0R3 recall (Z-2226-2009)Applied Medical Resources Corp2009-09-18
Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Sepa recall (Z-0023-2009)Applied Medical Resources Corp2008-10-07
Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator S recall (Z-0024-2009)Applied Medical Resources Corp2008-10-07
Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separa recall (Z-0025-2009)Applied Medical Resources Corp2008-10-07
Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator recall (Z-0026-2009)Applied Medical Resources Corp2008-10-07
Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Acc recall (Z-0027-2009)Applied Medical Resources Corp2008-10-07
Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shield recall (Z-0028-2009)Applied Medical Resources Corp2008-10-07
Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii A recall (Z-0029-2009)Applied Medical Resources Corp2008-10-07
SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3856, SIZE 6F x 24 recall (Z-2219-2008)Applied Medical Resources Corp2008-09-16
SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3857, SIZE 6F x 26 recall (Z-2220-2008)Applied Medical Resources Corp2008-09-16
SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3855, SIZE 6F x 22 recall (Z-2221-2008)Applied Medical Resources Corp2008-09-16
SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3827, SIZE 6F mult recall (Z-2222-2008)Applied Medical Resources Corp2008-09-16
SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: BS123, SIZE 6F mult recall (Z-2223-2008)Applied Medical Resources Corp2008-09-16
SILHOUETTE XTRAFLO DEVICE WITH SL-6 HYDROPHILIC COATING, MODEL NUMBER: B3957, SIZE 6F x 26 recall (Z-2224-2008)Applied Medical Resources Corp2008-09-16
The Applied GelPort Hand Access Device consists of a GelSeal Cap, Wound retractor (base). recall (Z-0151-06)Applied Medical Resources Corp2005-11-16
Applied Blunt Tip Trocar Models C0717 and C0718 recall (Z-0009-05)Applied Medical Resources Corp2004-10-05

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Every clearance here is in the API, with alerts when new ones post.