9,094 results · 51ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

AMI INC.

FDA registration
AMI INC.·1 product·🇰🇷 South Korea

PICO LEGEND

FDA UDI
AMI Inc.·08800042100292·

BIOXEL

FDA UDI
AMI Inc.·08800042100018·

Q-MASTER

FDA UDI
AMI Inc.·08800042100001·

UNICEL® DXC 600 PRO SYNCHRON ® CHEMISTRY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·January 10, 2011

SYNCHRON LX® I 725 CLINICAL SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code MMI·July 23, 2010

ACCESS® 2 IMMUNOASSAY SYSTEM

FDA Adverse Event
Injury ·BECKMAN COULTER, INC.·Product code MMI·January 19, 2012

UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·January 10, 2011

NOT APPLICABLE (INCIDENT OCCURRED IN THE BCI WAREHOUSE)

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·July 6, 2010

UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·July 6, 2010

UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·July 6, 2010

ACCESS® 2 IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code MMI·March 3, 2011

UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER

FDA Adverse Event
Other ·BECKMAN COULTER, INC.·Product code JJE·September 24, 2008

ACCESS® 2 IMMUNOASSAY SYSTEM

FDA Adverse Event
Injury ·BECKMAN COULTER, INC.·Product code MMI·January 19, 2012

IMPELLA

FDA Adverse Event
Death ·ABIOMED, INC. - 1220648·Product code OZD·April 2, 2026

IMPELLA

FDA Adverse Event
Death ·ABIOMED, INC. - 1220648·Product code OZD·March 26, 2026

IMPELLA

FDA Adverse Event
Death ·ABIOMED, INC. - 1220648·Product code OZD·March 5, 2026

UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code MMI·December 6, 2010

UNICEL® DXC 600I ACCESS® IMMUNOASSAY SYSTEM.

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·March 7, 2011

UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code JJE·December 9, 2011