9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Noxturnal Web
FDA 510(k)
FDA Class 2
·Neurology
fX
Device
EU MDD
·
Eu Md Class 3
·Bonegraft Biomaterials Co.·On the market·32 countries
XN CAL
FDA 510(k)
FDA Class 2
·Hematology
ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 19, 2014
PROLENE POLYPROPYLENE MESH
FDA Adverse Event
Injury
·ETHICON·Product code FTL·September 22, 2011
GYNECARE TVT-AA ABDOMINAL
FDA Adverse Event
Injury
·ETHICON SARL·Product code OTN·August 1, 2013
fX® Bioabsorbable Cannulated Screw 3.2x16 mm
Basic UDI-DI
EU MDD
·
Eu Md Class 3
·Bonegraft Biomaterials Co.·1 device
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021