Applied Medical Resources Corp

Model Numbers: Lot Numbers A4402: 1157054, 1163804, 1170473. A4403: 1157060, 1162689, 1166031, 1169109. A4404: 1160223, 1163803, 1166725, 1171181. A4405: 1155214, 1157053, 1161472, 1162967, 1164628, 1168912. A4406: 1155428, 1162945, 1167745, 1170042. A4407: 1154478, 1162866, 1168604. A4408: 1163626. A4F00: 1164152, 1164627, 1168666. A4F01: 1156256, 1160007, 1163628, 1168231. A4F02: 1156522, 1161792, 1170399. A4F03: 1155855, 1157052, 1161793, 1160310, 1159725, 1163215, 1163961, 1167855, 1169632, 1164626, 1165853. A4F04: 1155427, 1160221, 1161791, 1156935, 1171883, 1169729, 1167751, 1165778, 1163384, 1172598. A4F05: 1155854, 1154446, 1156936, 1155230, 1161471, 1160222, 1159414, 1161998, 1163216, 1163962, 1167440, 1166463, 1164625, 1165323, 1168911. A4F06: 1155856, 1154435, 1158624, 1161997, 1164149, 1165777, 1169013. A4F07: 1171170, 1156271, 1167414, 1164151. A4F08: 1168855, 1155648. CE0260ST: 1164307, 1168569. CE0280ST: 1164351. CE0340ST: 1164348. CE0380ST: 1164308, 1164337, 1166033, 1169029, 1166281, 1166032. CE0440ST: 1164336, 1168610. CE0480ST: 1164303, 1164302, 1164335, 1164304, 1166468, 1168605, 1166284, 1166283. CE0580ST: 1164345, 1164346, 1168613. CE0680ST: 1164330, 1166470. CE0780ST: 1164354. CE0340: 1166904. CE0380: 1164344. CE0440: 1164347, 1168609. CE0480: 1164343. CE0580: 1164349. CE0680: 1164353 CE0780: 1169926.

Cardiovascular Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Germany, Ecuador, Estonia, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Italy, Republic of Korea, Libyan Arab Jamahiriya, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Taiwan, and South Africa.

Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): || Model Numbers & Description: || A4402, 3F-40CM, SYNTEL RT-EMB; || A4403, 3F-80CM, SYNTEL RT-EMB; || A4404, 4F-40CM, SYNTEL RT-EMB; || A4405, 4F-80CM, SYNTEL RT-EMB; || A4406, 5F-80CM, SYNTEL RT-EMB; || A4407, 6F-80CM, SYNTEL RT-EMB; || A4408, 7F-80CM, SYNTEL RT-EMB; || A4F00, 2F-60CM (PREM) SYNTEL CATHETER; || A4F01, 2F-80CM, (PREM) SYNTEL CATHETER; || A4F02, 3F-40CM, (PREM) SYNTEL CATHETER; || A4F03, 3F-80CM, (PREM) SYNTEL CATHETER; || A4F04, 4F-40CM, (PREM) SYNTEL CATHETER; || A4F05, 4F-80CM, (PREM) SYNTEL CATHETER; || A4F06, 5F-80CM, (PREM) SYNTEL CATHETER; || A4F07, 6F-80CM, (PREM) SYNTEL CATHETER; || A4F08, 7F-80CM, (PREM) SYNTEL CATHETER; || CE0260ST, L2F-60CM PREM SYNTEL CATH; || CE0280ST, L2F-80CM PREM SYNTEL CATH; || CE0340ST, 3F-40cm (PREM) SYNTEL CATHETER; || CE0380ST, 3F-80CM PREM SYNTEL CATH; || CE0440ST, 4F-40CM PREM SYNTEL CATH; || CE0480ST, 4F-80CM PREM SYNTEL CATH; || CE0580ST, 5F-80CM PREM SYNTEL CATH; || CE0680ST, 6F-80cm (PREM) SYNTEL CATHETER; || CE0780ST, 7F-80CM PREM SYNTEL CATH; || CE0340, 3F-40cm, SYNTEL RT-EMB; || CE0380, 3F-80cm, SYNTEL RT-EMB; || CE0440, 4F-40cm, SYNTEL RT-EMB; || CE0480, 4F-80cm, SYNTEL RT-EMB; || CE0580, 5F-80cm, SYNTEL RT-EMB; || CE0680, 6F-80cm, SYNTEL RT-EMB; || CE0780, 7F-80cm SYNTEL RT-EMB. || BARD Embolectomy Catheters are indicated for the removal of emboli and thrombi from the peripheral arterial system. These devices consist of a catheter body with a latex-free balloon on the distal end and an inflation hub on the proximal end.

Model Numbers: Lot Numbers A4752: 1165670. A4754: 1156762. A4762: 1155852, 1165674. CB052308: 1164350. CB054008: 1164305. CB062313: 1164306.

Gastroenterology-Urology Devices

2

Yes

Worldwide Distribution-USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Germany, Ecuador, Estonia, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Italy, Republic of Korea, Libyan Arab Jamahiriya, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Taiwan, and South Africa.

Biliary Catheters (Models A47XX and CB0XXXXX): || Model Numbers & Description: || A4752, SYNTEL BILIARY 5F-23CM CATHETER; || A4754, SYNTEL BILIARY 5F-40CM CATHETER; || A4762, SYNTEL BILIARY 6F-23CM CATHETER; || CB052308, SYNTEL BILIARY 5F-23CM CATH; || CB054008, SYNTEL BILIARY 5F-40CM CATH; || CB062313, SYNTEL BILIARY 6F-23CM CATH. || Biliary Catheters are indicated for the removal of stones and ductal debris from the biliary system.

Model Numbers: Lot Numbers IRR-023-10F: 1158230. IRR-080-4F: 1156082, 1170185, 1164648. IRR-080-6F: 1158960.

Cardiovascular Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Germany, Ecuador, Estonia, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Italy, Republic of Korea, Libyan Arab Jamahiriya, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Taiwan, and South Africa.

Irrigation Catheters (Models IRR-XXX-XX): || Model Numbers & Description: || IRR-023-10F,CATHETER IRRIGATION 10F 23CM; || IRR-080-4F, CATHETER, IRRIGATION 4F 80CM; || IRR-080-6F, CATHETER, IRRIGATION 6F 80CM. || Irrigation Catheters are indicated for irrigation in the peripheral vascular system and biliary tree.

C4130, 5MM X 35CM DIRECT DRIVE GRASPER 10/BX: 1109421, 1109787, 1110340, 1119363, 1120205, 1120207, 1121053, 1121057, 1121624, 1121756, 1122974, 1123411, 1123710, 1123872, 1124355, 1124556, 1124717, 1125445, 1125447, 1125710, 1125887, 1126120, 1127581, 1127583, 1128329, 1128334, 1128336, 1128434, 1129471, 1129473, 1130479, 1131482, 1131483, 1131484, 1131485, 1131486, 1132587, 1133099, 1134795, 1134796, 1134799, 1135529, 1135553, 1136810, 1136814, 1137509, 1137511, 1138374, 1138557, 1139245, 1139247, 1139968, 1141460, 1141461, 1141462, 1141857, 1141859, 1142395, 1142398, 1143129, 1143130, 1143133, 1143609, 1144837, 1144838, 1144840, 1144841.

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA (nationwide) including the state of Puerto Rico and the countries of: Australia, Bahrain, Canada, Chile, Colombia, Ecuador, Europe, India, Israel, Jordon, Kuwait, Lebanon, Libya, Malaysia, Mexico, Peru, Qatar, Singapore, , South Africa, South Korea, Saudi Arabia. Taiwan, Thailand, Turkey, and Venezuela.

Direct Drive Grasper, Model numbers C4130, 5MM X 35CM DIRECT DRIVE GRASPER 10/BX || Intended Usage: The grasper is indicated for grasping and manipulating tissue during general or laparoscopic surgery. The instrument is not intended for use when minimally invasive techniques are contraindicated. Complications which have been reported secondary to surgical grasping and manipulation include, but are not limited to: local trauma, injury, and tissue necrosis.

C4140, 5MM X 45CM DIRECT DRIVE GRASPER 10/BX:  1109789, 1110338, 1120502, 1121622, 1122986, 1125449, 1126857, 1128330, 1128927, 1129474, 1130990, 1131764, 1132586, 1136813, 1137334, 1139969, 1141463, 1142396, 1143131.

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA (nationwide) including the state of Puerto Rico and the countries of: Australia, Bahrain, Canada, Chile, Colombia, Ecuador, Europe, India, Israel, Jordon, Kuwait, Lebanon, Libya, Malaysia, Mexico, Peru, Qatar, Singapore, , South Africa, South Korea, Saudi Arabia. Taiwan, Thailand, Turkey, and Venezuela.

Direct Drive Grasper, Model number C4140, 5MM X 45CM DIRECT DRIVE || GRASPER 10/BX || Intended Usage: The grasper is indicated for grasping and manipulating tissue during general or laparoscopic surgery. The instrument is not intended for use when minimally invasive techniques are contraindicated. Complications which have been reported secondary to surgical grasping and manipulation include, but are not limited to: local trauma, injury, and tissue necrosis.