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OMF ASP System

FDA 510(k)
FDA Class 2 ·Dental

ABIOMED, INC.

FDA registration
ABIOMED, INC.·10 products·🇺🇸 United States

SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS

FDA 510(k)
FDA Class 2 ·Radiology

GRIDLOCK 195 ADHESIVE

FDA 510(k)
FDA Class 2 ·Dental

1220648-1999-00039

FDA Adverse Event
Malfunction ·December 28, 1999

1220648-2018-00046

FDA Adverse Event
Malfunction ·May 4, 2018

AUTOMATED IMPELLA CONTROLLER

FDA Adverse Event
Malfunction ·ABIOMED, INC.·Product code OZD·February 5, 2025

AUTOMATED IMPELLA CONTROLLER

FDA Adverse Event
Malfunction ·ABIOMED, INC.·Product code OZD·June 3, 2024

AUTOMATED IMPELLA CONTROLLER

FDA Adverse Event
Malfunction ·ABIOMED, INC.·Product code OZD·January 23, 2024

AUTOMATED IMPELLA CONTROLLER

FDA Adverse Event
Malfunction ·ABIOMED. INC.·Product code OZD·November 23, 2024

AUTOMATED IMPELLA CONTROLLER

FDA Adverse Event
Malfunction ·ABIOMED, INC.·Product code OZD·January 22, 2024

AUTOMATED IMPELLA CONTROLLER

FDA Adverse Event
Malfunction ·ABIOMED, INC.·Product code OZD·October 17, 2023

IMPELLA 5.5

FDA Adverse Event
Injury ·ABIOMED, INC.·Product code OZD·January 3, 2025

AUTOMATED IMPELLA CONTROLLER

FDA Adverse Event
Malfunction ·ABIOMED, INC.·Product code OZD·November 15, 2024

AUTOMATED IMPELLA CONTROLLER

FDA Adverse Event
Malfunction ·ABIOMED, INC.·Product code OZD·November 21, 2023

AUTOMATED IMPELLA CONTROLLER

FDA Adverse Event
Malfunction ·ABIOMED, INC.·Product code OZD·November 6, 2023

AUTOMATED IMPELLA CONTROLLER

FDA Adverse Event
Malfunction ·ABIOMED, INC.·Product code OZD·December 4, 2023

KIT, 14FR INTRODUCER, 13&25 CM, ABMD

FDA Adverse Event
Injury ·ABIOMED, INC.·Product code DYB·March 10, 2025

AUTOMATED IMPELLA CONTROLLER

FDA Adverse Event
Malfunction ·ABIOMED, INC.·Product code OZD·August 23, 2024

IMPELLA CP

FDA Adverse Event
Injury ·ABIOMED, INC.·Product code OZD·June 4, 2024