14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED
FDA 510(k)
FDA Class 2
·Orthopedic
4200 PNEUMATIC MOUTH SHUTTER
FDA 510(k)
FDA Class 2
·Anesthesiology
RS-7800 MINIPUMP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYNCHRON® ALT REAGENT, 2 X 200 TEST
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code CKA·July 26, 2011
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE HEALTH SOLUTIONS INC.·Product code LZG·January 30, 2013
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·January 27, 2011
UNKNOWN
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·July 31, 2014
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 13, 2021
Ortho Pack, part number PSS3466(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 20, 2024
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GKZ·July 15, 2021
BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·November 30, 2023
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 24, 2020
BD TRUCOUNT¿ TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 2, 2025