10,000 results · 69ms · Sources: EU EUDAMED, US FDA

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FDA 510(k)
FDA Class 2 ·Neurology

ACCESS CEA

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code DHX·September 22, 2015

ACCESS CEA

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code DHX·September 22, 2015

LIQUICHEK TUMOR MARKER CONTROL

FDA Adverse Event
Malfunction ·BIO-RAD LABORATORIES·Product code JJY·November 20, 2018

ACCESS CEA

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code DHX·September 22, 2015

ACCESS CEA

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code DHX·September 22, 2015

ACCESS CEA

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code DHX·September 22, 2015

ACCESS CEA

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code DHX·September 22, 2015

ACCESS CEA

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code DHX·September 22, 2015

XIA SERRATO 8.5X50 POLYAXIAL SCREW

FDA Adverse Event
Malfunction ·STRYKER SPINE-US·Product code NKB·April 14, 2026

LIQUICHEK DIABETES CONTROL LEVEL 1

FDA Adverse Event
Malfunction ·BIO-RAD LABORATORIES INC·Product code GGM·September 25, 2018

VIROTROL I

FDA Adverse Event
Malfunction ·BIO-RAD LABORATORIES, INC.·Product code KSF·February 6, 2018

DISSECTOR, 3.0MM X 7CM

FDA Adverse Event
Malfunction ·ARTHREX, INC.·Product code GFA·January 24, 2024

LIQUICHEK IMMUNOASSAY PREMIUM CONTROL, LEVEL 3

FDA Adverse Event
Malfunction ·BIO-RAD LABORATORIES, INC.·Product code JJY·September 18, 2019

CADD-LEGACY PLUS PUMP

FDA Adverse Event
Malfunction ·ST PAUL·Product code FRN·July 21, 2022

LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LEVEL 1A

FDA Adverse Event
Malfunction ·BIO-RAD LABORATORIES, INC.·Product code JJY·February 24, 2020

CADD ADMINISTRATION SET WITH FLOW STOP

FDA Adverse Event
Malfunction ·ST PAUL·Product code FPA·July 21, 2022

CADD CASSETTE RESERVOIRS - FLOW STOP

FDA Adverse Event
Malfunction ·ST PAUL·Product code FPA·July 21, 2022

HEMOLUNG RAS

FDA Adverse Event
Malfunction ·ALUNG TECHNOLOGIES, INC·Product code DQR·January 18, 2019

LIQUICHEK IMMUNOASSAY PLUS CONTROL, TRILEVEL

FDA Adverse Event
Malfunction ·BIO-RAD LABORATORIES, INC.·Product code JJY·March 9, 2020