7 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup
FDA 510(k)
FDA Class 2
·Clinical Toxicology
FreeStyle Libre 3 Continuous Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Ulthera System (UC-1 Control Unit PRIME)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD FIRST PICC
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·September 7, 2011
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·November 11, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 24, 2013
ALBOGRAFT POLYESTER VASCULAR GRAFT
FDA Adverse Event
Injury
·LEMAITRE VASCULAR, INC.·Product code MAL·November 5, 2020