13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Overjet Periapical Radiolucency Assist
FDA 510(k)
FDA Class 2
·Radiology
BD BBL™ Sensi-Disc™ Clarithromycin 15 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902316788·BD BBL™ Sensi-Disc™ Clarithromycin 15 µg
iCE-SG Subcutaneous Electrode Arrays
FDA 510(k)
FDA Class 2
·Neurology
HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
CONTOUR® PLUS BLUE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 13, 2025
BD BBL Sensi Disc Clarithromycin- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231678¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 4, 2014
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·September 1, 2011
PELVICOL 6 X 8 CM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE ...·Product code FTL·July 12, 2013
CONTOUR® PLUS BLUE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·February 11, 2025
CONTOUR® CARE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 13, 2025
BD BBL Sensi Disc Clarithromycin- 15 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231678
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTN·January 8, 2024
CONTOUR® CARE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 7, 2025