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Abiomed, Inc.

19 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
14Fr Low Profile Introducer Kit (K252766)Abiomed, Inc.2025-10-08
Abiomed 14Fr Low Profile Introducer Kit (K241708)Abiomed, Inc.2024-08-06
preCARDIA Occlusion System (K221294)Abiomed, Inc.2023-06-30
OXY-1 System (K223161)Abiomed, Inc.2023-02-23
Abiomed 14Fr Low Profile Introducer Set (K222113)Abiomed, Inc.2022-10-13
Impella XR Sheath Set (K202330)Abiomed, Inc.2020-12-07
OXY-1 System (K200109)Abiomed, Inc.2020-10-23
Abiomed 23 Fr Sheath (K201116)Abiomed, Inc.2020-06-15
Impella CP Introducer (K192769)Abiomed, Inc.2019-11-18
IMPELLA 2.5 PLUS CATHETER (K112892)Abiomed, Inc.2012-09-06
IMPELLA CONTROLLER WITH FLOW CONTROL (K110845)Abiomed, Inc.2011-04-27
IMPELLA CONTROLLER (K093801)Abiomed, Inc.2010-07-08
IMPELLA 5.0 CATHETER FAMILY (K083111)Abiomed, Inc.2009-04-16
IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM (K063723)Abiomed, Inc.2008-05-30
SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE (K070225)Abiomed, Inc.2007-12-13
SUPRACOR BALLOON CATHETER (K062582)Abiomed, Inc.2006-12-14
ABIODENT PERIOTEMP(R) SYSTEM (K911643)Abiomed, Inc.1991-07-09
ABIOMED BODY LEAD ANALYZER MODEL 200/20 (K900574)Abiomed, Inc.1990-03-15
ABIOMED PERIOTEMP(TM) PROBE (K885075)Abiomed, Inc.1989-02-13

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Every clearance here is in the API, with alerts when new ones post.