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Cobe Cardiovascular, Inc

21 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
dideco Preassembled Surgical Wash Set, Compact , Cobe part numbers WS55C, WS125C, WS225C, recall (Z-1488-06)Cobe Cardiovascular, Inc2006-09-09
dideco Preassembled Surgical Wash Set, Electa Essential , Cobe part numbers WS55E, WS125E, recall (Z-1489-06)Cobe Cardiovascular, Inc2006-09-09
Cobe STAT PAC, Autotransfusion Set (Made with Compact Wash Sets), Cobe Product Codes: AS4C recall (Z-1490-06)Cobe Cardiovascular, Inc2006-09-09
Cobe STAT PAC Autotransfusion Set (made with Electa Wash Set), Cobe Product Codes: ASCBFE2 recall (Z-1491-06)Cobe Cardiovascular, Inc2006-09-09
Cobe Optima XP Hollow Fiber Membrane Oxygenator/Reservoir, Sterile, (Standalone Systems) C recall (Z-1422-06)Cobe Cardiovascular, Inc2006-08-24
Cobe CML Duo Flat Sheet Membrane Oxygenator/Reservoir, sterile, (Standalone systems). Cata recall (Z-1423-06)Cobe Cardiovascular, Inc2006-08-24
Cobe Optimin Hollow Fiber Sealed System, Oxygenator/Reservoir, Sterile, (Standalone system recall (Z-1424-06)Cobe Cardiovascular, Inc2006-08-24
Cobe Optima XP Hollow Fiber Membrane Oxygenator, Sterile, (Custom Heart/Lung Packs), Catal recall (Z-1425-06)Cobe Cardiovascular, Inc2006-08-24
Cobe CML Duo Flat Sheet Membrane Oxygenator, sterile, (Custom Heart/Lung Packs), Catalog n recall (Z-1426-06)Cobe Cardiovascular, Inc2006-08-24
Cobe Optimin Hollow Fiber Sealed System, Sterile, (Custom Heart / Lung Pack), Catalog Numb recall (Z-1427-06)Cobe Cardiovascular, Inc2006-08-24
Cobe Optima XP Hollow Fiber Membrane Oxygenator, Non-Sterile, Catalog Number 436422974, CO recall (Z-1428-06)Cobe Cardiovascular, Inc2006-08-24
Cobe CML Duo Flat Sheet Membrane Oxygenator, Non-sterile, Catalog Number: 436122974, COBE recall (Z-1429-06)Cobe Cardiovascular, Inc2006-08-24
Custom heart lung perfusion packs recall (Z-0265-06)Cobe Cardiovascular, Inc2005-12-02
ASY Brat 2 Procedure Set, for blood recovery & autotransfusion. recall (Z-1069-05)Cobe Cardiovascular, Inc2005-08-03
ASY, Brat 2 Pack Procedure Set recall (Z-1070-05)Cobe Cardiovascular, Inc2005-08-03
ASY Brat 2 Procedure Set recall (Z-1071-05)Cobe Cardiovascular, Inc2005-08-03
ASY, Brat Pack Procedure Set recall (Z-1072-05)Cobe Cardiovascular, Inc2005-08-03
ASY Brat 2 Procedure Set recall (Z-1073-05)Cobe Cardiovascular, Inc2005-08-03
ASY, Brat 2 Procedure Set recall (Z-1074-05)Cobe Cardiovascular, Inc2005-08-03
Cardioplegia Pack BCD Vanguard Ratio 4:1 with Shunt recall (Z-1009-04)Cobe Cardiovascular, Inc2004-07-20
Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt. recall (Z-0960-03)Cobe Cardiovascular, Inc2003-07-02

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