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  • Dispositivo 124
  • Fabricante 32
  • Evento 124969
  • Implante 6
Direct Drive clip applicators, reference CA090 and kits that include the Direct Drive clip applic...
  • Modelo / Serial
  • Manufacturer
    Applied Medical Resources
  • 1 Event
    • Retiro De Equipo O Alerta De Seguridad para Direct Drive clip applicators, reference CA090 and kits that include the Direct Drive clip applicator, reference CA090
EPIX Universal Clips Applicator CA500 Lot 1231562
  • Modelo / Serial
  • Manufacturer
    Applied Medical Resources
  • 1 Event
    • Retiro De Equipo O Alerta De Seguridad para EPIX Universal Clips Applicator CA500 Lot 1231562
Advanced Access Platform GelPOINT®, reference CNGL2
  • Modelo / Serial
  • Manufacturer
    Applied Medical Resources
  • 1 Event
    • Retiro De Equipo O Alerta De Seguridad para Advanced Access Platform GelPOINT®, reference CNGL2
Epix® and Direct Drive pliers, references C4130 and C4140
  • Modelo / Serial
  • Manufacturer
    Applied Medical Resources
  • 1 Event
    • Retiro De Equipo O Alerta De Seguridad para Epix® and Direct Drive pliers, references C4130 and C4140
CA090 Direct Drive Clip Appliers
  • Modelo / Serial
  • Descripción del producto
    Medical instruments for use in humans - visceral surgery
  • Manufacturer
    Applied Medical
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de CA090 Direct Drive Clip Appliers
EB010 - Voyant 5mm Fusion / 37mm 6NE
  • Modelo / Serial
  • Descripción del producto
    Medical electronics / Electromedical devices - electrotherapy
  • Manufacturer
    Applied Medical
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de EB010 - Voyant 5mm Fusion / 37mm 6NE
certain lots of the Inzii 12/15mm retrieval system
  • Modelo / Serial
  • Descripción del producto
    Optics / Precision engineering - precision instruments for gastrointestinal and urological endoscopy and hysteroscopy
  • Manufacturer
    Applied Medical
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de certain lots of the Inzii 12/15mm retrieval system
GelPOINT Advanced Access Platform
  • Modelo / Serial
  • Descripción del producto
    Dressings / Pads - others
  • Manufacturer
    Applied Medical
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de GelPOINT Advanced Access Platform
Bard® thrombectomy and Bard® biliary and cholangiography catheters
  • Modelo / Serial
  • Descripción del producto
    Injections / Infusions / Transfusions / Dialysis - catheters
  • Manufacturer
    Applied Medical
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Bard® thrombectomy and Bard® biliary and cholangiography catheters
vascular catheters
  • Modelo / Serial
  • Descripción del producto
    Injections / Infusions / Transfusions / Dialysis - catheters
  • Manufacturer
    Applied Medical
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de vascular catheters
DIRECT DRIVE GRASPERS
  • Modelo / Serial
  • Descripción del producto
    Medical instruments for use in humans
  • Manufacturer
    Applied Medical
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de DIRECT DRIVE GRASPERS
CA500 Epix Universal Clip Applier
  • Modelo / Serial
  • Descripción del producto
    Medical instruments for use in humans - general instruments
  • Manufacturer
    Applied Medical Europe BV
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de CA500 Epix Universal Clip Applier
the Epix® and Direct Drive Laparoscopic Graspers
  • Modelo / Serial
  • Descripción del producto
    Optics / Precision engineering - endoscopes
  • Manufacturer
    Applied Medical Resources
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de the Epix® and Direct Drive Laparoscopic Graspers
EA010, VOYANT ESG 1/BX
  • Modelo / Serial
  • Descripción del producto
    Medical electronics / Electromedical devices - electrotherapy
  • Manufacturer
    Applied Medical Resources Corporation
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de EA010, VOYANT ESG 1/BX
Kii Optical Z-Thread Dual Packs
  • Modelo / Serial
  • Descripción del producto
    Medical instruments for use in humans - visceral surgery
  • Manufacturer
    Applied Medical Resources Corporation
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Kii Optical Z-Thread Dual Packs
Inzii 12/15mm Retrieval System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Applied Medical Inzii 12/15mm Retrieval System
  • Manufacturer
    Applied Medical
  • 1 Event
    • Alerta De Seguridad para Inzii 12/15mm Retrieval System
CA090, Direct Drive® Clip Applier 3/BX
  • Modelo / Serial
    Catalog Number: 100975401; 101416101 Model Number: CA090 and any associated kits including the CA090 Batch Number: 1190640 1191260 1191261 1191369 1192248 1191425 1192573 1192574 1193046 1193175 1193435 1193512 1194493 1194494 1195770 1195771 1195792 1195793 1196010 1196014 1196211 1196210 1196361 1196687 1196362 1196686 1196688 1196719 1196735 1196736 1196737 1196805 1197159 1197913 1197826 1197827 1197825 1197915 1197916 1197914 1197918 1198995 1198996 1198997 1199797 1199798 1199851 1200211 1200212 1199852 1200414 1200213 1200589 1201543 1201565 1201885 1201886 1200713 1201982 1202651 1202652 1202979 1203113 1203114 1203135 1203291 1203560 1203729 1204085 1204608 1204797 1204798 1205062 1205681 1205682 1206045 1205465 1206046 1206549 1207309 1207320 1206434 1207746 1207744 1207745 1207749 1209141 1209142 1209143 1209155 1209144 1209156 1209552 1209768 1209859 1210512 1209941 1210851 1210998 1211597 1211038 1211039 1211050 1211886 1212666 1212768 1213133 1213318 1214521 1215840 1216197 1217070 1217759 1218289 1218680 1219647 1216169 1216180 1216181 1218682 1218683 1221320 1221468 1223112 1221737 1222986 1222987 1223891 1226026 1224185 1224485 1224486 1227284 1227290 1228149 1227674 1224395 1228544 1228555 1229106 1229365 1230972 1232955 1229867 1229866 1233475 1230403 1233476 1232741 1234102 1234360 1234374 1234761 1235799 1235901 1236014 1236009 1236552 1237475 1237565 1238425 1234103 1237567 1237568 1238513 1239837 1238600 1238621 1238142 1239402 1239431 1240610 1240611 1241091 1242200 1241094 1241859 1242585 1242586 1243587 1244385 1244386 1244387 1245992 1245710 1243604 1244232 1246219 1247895 1249462 1250211 1249463 1251406 1251459 1252764 1253479 1253491 1253490 1254855 1255697 1255698 1257562 1253273 1257642 1257643 1257794 1258172 1258305 1258306 1258613 1258730 1258944 1259220 1259221 1259222 1259004 1259017 1259046 1262387 1262388 1261739 1261905 1262795 1262797 1263340 1263342 1263601 1263957 1263958 1263438 1264087 1262389 1258614 1264491 1264913 1265006
  • Descripción del producto
    Inactive implantable medical devices
  • Manufacturer
    Applied Medical Resources
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de CA090, Direct Drive® Clip Applier 3/BX
Kii Optical Z-Thread Dual Packs-trocar
  • Modelo / Serial
  • Descripción del producto
    Disposable products
  • Manufacturer
    Applied Medical Resources
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Kii Optical Z-Thread Dual Packs-trocar
Device Recall Surgical Clamp Inserts
  • Modelo / Serial
    1112662,1115821,1121413,1122062, 1122163,1125949,1129996,1130225, 1131354
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, and Michigan; and countries of: Japan, Israel, and Singapore.
  • Descripción del producto
    Surgical Clamp Inserts, Model#G-8650, 86MM Insert Soft/Fibra 15/Bx || Surgical Clamps and inserts are indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery. The clamps are available in 33, 45, 61 and 86 mm jaw lengths and the inserts are designed to snap easily into the clamp jaws.
  • Manufacturer
    Applied Medical Resources Corp
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Surgical Clamp Inserts
Device Recall Surgical Clamp Inserts
  • Modelo / Serial
    1114700,1117956,1122073,1128221, 1130157,1133116
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, and Michigan; and countries of: Japan, Israel, and Singapore.
  • Descripción del producto
    Surgical Clamp Inserts, Model#G-8600, 86MM Insert Soft/Traction, 15/Bx || Surgical Clamps and inserts are indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery. The clamps are available in 33, 45, 61 and 86 mm jaw lengths and the inserts are designed to snap easily into the clamp jaws.
  • Manufacturer
    Applied Medical Resources Corp
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Surgical Clamp Inserts
Device Recall Direct Drive Grasper
  • Modelo / Serial
    1112177, 1112935, 1123914, 1126274, 1132432, 1128149, 1129688, 1132432, 1133852, 1129688, 1133852, 1135372, 1136464, 1137996, 1139978, 1141874, 1144295, 1146403, 1125156, 1125279, 1126853, 1126853, 1130549, 1111831, 1111947, 1112024, 1125131, 1135284, 1139948, 1111842, 1138635, 1143347, 1111842, 1138635, 1143347, 1125499, 1132309, 1133063, 1134258, 1137548, 1138923, 1143888, 1146663, 1111843, 1130029, 1130029, 1139271, 1139365, 1145313, 1112273, 1124108, 1127084, 1131634, 1136135, 1127363, 1125662, 1125662, 1126390, 1127004, 1128850, 1130615, 1131158, 1136058, 1136556, 1139202, 1139316, 1139316, 1139316, 1135424, 1141142, 1146443, 1147253.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    Direct Drive Grasper, VARIOUS KITS CONTAINING EITHER C4130 || OR C4140 || 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.
  • Manufacturer
    Applied Medical Resources Corp
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Direct Drive Grasper
Device Recall Direct Drive Grasper
  • Modelo / Serial
    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.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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.
  • Manufacturer
    Applied Medical Resources Corp
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Direct Drive Grasper
Device Recall Direct Drive Grasper
  • Modelo / Serial
    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.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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.
  • Manufacturer
    Applied Medical Resources Corp
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Direct Drive Grasper
Irrigation Catheters
  • Modelo / Serial
    Model Numbers: Lot Numbers IRR-023-10F: 1158230. IRR-080-4F: 1156082, 1170185, 1164648. IRR-080-6F: 1158960.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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.
  • Manufacturer
    Applied Medical Resources Corp
  • 1 Event
    • Retiro De Equipo (Recall) de Irrigation Catheters
Embolectomy Catheters
  • Modelo / Serial
    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.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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.
  • Manufacturer
    Applied Medical Resources Corp
  • 1 Event
    • Retiro De Equipo (Recall) de Embolectomy Catheters
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Aviso

Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.

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