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Cook Inc.

380 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( recall (Z-0525-05)Cook, Inc.2005-02-03
Cook brand Zenith AAA Converter with the H&L-B One-Shot Introducer System, preloaded conve recall (Z-1160-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Endovascular Graft Iliac Leg Extensions - diameter 14 mm - length 55 recall (Z-1161-04)Cook, Inc.2004-07-27
Cook brand Reorder # PLVTW-14.0-38-30-BNS. Silhouette Transitionless Peel-Away Introducer recall (Z-1162-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System recall (Z-1163-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System recall (Z-1164-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System recall (Z-1165-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System recall (Z-1166-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System recall (Z-1167-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System recall (Z-1168-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System recall (Z-1169-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System recall (Z-1170-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System recall (Z-1171-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System recall (Z-1172-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System recall (Z-1173-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System recall (Z-1174-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Bifurcated main body graft with the H&L-B One-Shot Introducer System recall (Z-1175-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1176-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1177-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1178-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1179-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1180-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1181-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1182-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1183-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1184-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1185-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1186-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1187-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1188-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1189-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1190-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1191-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1192-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1193-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1194-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1195-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1196-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1197-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1198-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1199-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1200-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1201-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1202-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1203-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1204-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1205-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1206-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1207-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1208-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1209-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1210-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1211-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1212-04)Cook, Inc.2004-07-27
Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded recall (Z-1213-04)Cook, Inc.2004-07-27
Cook brand Keller-Timmermans Introducer Set, straight with Rutner adapter includes: sheath recall (Z-1214-04)Cook, Inc.2004-07-27
Cook brand Keller-Timmermans Introducer Set, curved with Rutner adapter includes: sheath 1 recall (Z-1215-04)Cook, Inc.2004-07-27
Cook brand Keller-Timmermans Introducer Set, straight with Rutner adapter includes: sheath recall (Z-1216-04)Cook, Inc.2004-07-27
Cook brand Keller-Timmermans Introducer Set, curved with Rutner adapter includes: sheath 1 recall (Z-1217-04)Cook, Inc.2004-07-27
Cook brand Zenith rupture main body graft, preloaded graft measuring 22 mm diameter at pro recall (Z-1218-04)Cook, Inc.2004-07-27
Cook brand Zenith rupture main body graft, preloaded graft measuring 26 mm diameter at pro recall (Z-1219-04)Cook, Inc.2004-07-27
Cook Polyvinyl Alcohol Foam (PVA ) Embolization Particles, particle size 47-90 microns, 1 recall (Z-1054-03)Cook, Inc.2003-07-29
Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 90-180 microns, 1 recall (Z-1055-03)Cook, Inc.2003-07-29
Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 180-300 microns, 1 recall (Z-1056-03)Cook, Inc.2003-07-29
Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 300-500 microns, 1 recall (Z-1057-03)Cook, Inc.2003-07-29
Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 500-710 microns, 1 recall (Z-1058-03)Cook, Inc.2003-07-29
Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 710-1000 microns, recall (Z-1059-03)Cook, Inc.2003-07-29
COOK Stiffened Micropuncture Introducer Set, 4 FR. Product Reorder Number: MPIS-401-10.0-S recall (Z-0425-03)Cook, Inc.2003-02-28
COOK Stiffened Micropuncture Introducer Set, 4 FR. Product Reorder Number: MPIS-401-10.0-S recall (Z-0426-03)Cook, Inc.2003-02-28
COOK Stiffened Micropuncture Introducer Set, 4 FR. Product Reorder Number: MPIS-401-10.0-S recall (Z-0427-03)Cook, Inc.2003-02-28
COOK Stiffened Micropuncture Introducer Set, 4 FR. Product Reorder Number: MPIS-401-15.0-S recall (Z-0428-03)Cook, Inc.2003-02-28
COOK Stiffened Micropuncture Introducer Set, 4 FR. Product Reorder Number: MPIS-401-20.0-S recall (Z-0429-03)Cook, Inc.2003-02-28
COOK Stiffened Micropuncture Introducer Set, 5 FR. Product Reorder Number: MPIS-501-10.0-S recall (Z-0430-03)Cook, Inc.2003-02-28
COOK Stiffened Micropuncture Introducer Set, 5 FR. Product Reorder Number: MPIS-501-10.0-S recall (Z-0431-03)Cook, Inc.2003-02-28
COOK Stiffened Micropuncture Introducer Set, 5 FR. Product Reorder Number: MPIS-501-10.0-S recall (Z-0432-03)Cook, Inc.2003-02-28
COOK Stiffened Micropuncture Introducer Set, 5 FR. Product Reorder Number: MPIS-501-10.0-S recall (Z-0433-03)Cook, Inc.2003-02-28
COOK Stiffened Micropuncture Introducer Set, 5 FR. Product Reorder Number: MPIS-501-10.0-S recall (Z-0434-03)Cook, Inc.2003-02-28
COOK Stiffened Micropuncture Introducer Set, 5 FR. Product Reorder Number: MPIS-501-15.0-S recall (Z-0435-03)Cook, Inc.2003-02-28
COOK Stiffened Micropuncture Introducer Set, 5 FR. Product Reorder Number: MPIS-501-15.0-S recall (Z-0436-03)Cook, Inc.2003-02-28
COOK Stiffened Micropuncture Introducer Set, 5 FR. Product Reorder Number: MPIS-501-15.0-S recall (Z-0437-03)Cook, Inc.2003-02-28
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Every clearance here is in the API, with alerts when new ones post.