45 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CONTOUR NEXT
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·February 24, 2014
CONTOUR NEXT
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·May 2, 2013
Luxatemp® Fluorescence
FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG1105870·Temporary crown and bridge material automix sys...
PROPATCH SOFT TISSUE REPAIR MATRIX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACTIVEECG
FDA 510(k)
FDA Class 2
·Cardiovascular
BD POSIFLUSH¿ NORMAL SALINE SYRINGE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code NGT·November 30, 2018
10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code NGT·November 29, 2018
BD POSIFLUSH¿ NS FILLED SYRINGE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code NGT·November 12, 2018
BD POSIFLUSH¿ NS FILLED SYRINGE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code NGT·November 19, 2018
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, NEUROMODULATION·Product code LGW·May 10, 2013
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code FRN·September 23, 2014
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 1, 2011
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 22, 2024
BD¿ POSIFLUSH
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code FOZ·January 25, 2019
LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 13, 2023
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 17, 2024
LOGIC FEMORAL PS CEM LEFT SZ 3.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 5, 2025
LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·June 30, 2022
LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 5, 2024