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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 20 Results
510(K) Number: K192769
 
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Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for... 2 01/05/2024 FEI # 1220648
Abiomed, Inc.
Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035... 2 01/05/2024 FEI # 1220648
Abiomed, Inc.
Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for int... 2 01/05/2024 FEI # 1220648
Abiomed, Inc.
Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introducti... 2 01/05/2024 FEI # 1220648
Abiomed, Inc.
Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Ca... 2 01/05/2024 FEI # 1220648
Abiomed, Inc.
Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-In... 2 01/05/2024 FEI # 1220648
Abiomed, Inc.
Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for... 2 01/05/2024 FEI # 1220648
Abiomed, Inc.
ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer P... 1 07/10/2026 FEI # 1220648
Abiomed, Inc.
ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. hear... 1 07/10/2026 FEI # 1220648
Abiomed, Inc.
ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product C... 1 07/10/2026 FEI # 1220648
Abiomed, Inc.
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