30 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOMET HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304256200·
OFFSET MODULAR HEAD PROVISIONAL
FDA UDI
Biomet Orthopedics, LLC·00880304308015·
WIRELESS TEMPERATURE MONITOR / MODELS ST323C AND ST323F.
FDA 510(k)
FDA Class 2
·General Hospital
GENSTRIP TEST STRIP MODEL 100-201
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
FDA Adverse Event
Malfunction
·COCHLEAR LTD·Product code MCM·June 1, 2020
INTRALASE FS LASER
FDA Adverse Event
Injury
·AMO MANUFACTURING USA, LLC·Product code HNO·November 5, 2010
LARGE NEEDLE DRIVER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 11, 2013
ALARIS PUMP MODULE
FDA Adverse Event
Death
·CAREFUSION CORPORATION·Product code FRN·September 25, 2014
CHROMID STREPTO B AGAR
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code PQZ·November 1, 2017
CHROMID STREPTO B AGAR
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code PQZ·November 1, 2017
ARNDT ENDOBRONCHIAL BLOCKER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code CBI·November 20, 2018
ARNDT ENDOBRONCHIAL BLOCKER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code CBI·December 11, 2018
ARNDT ENDOBRONCHIAL BLOCKER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code CBI·August 17, 2020
ARNDT ENDOBRONCHIAL BLOCKER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code CBI·May 16, 2019
ARNDT ENDOBRONCHIAL BLOCKER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code CBI·April 4, 2018
ARNDT ENDOBRONCHIAL BLOCKER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code CBI·June 15, 2021
ARNDT ENDOBRONCHIAL BLOCKER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code CBI·June 17, 2022
ARNDT ENDOBRONCHIAL BLOCKER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code CBI·April 22, 2024
ARNDT ENDOBRONCHIAL BLOCKER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code CBI·November 19, 2020