12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
QuadraSphere Microspheres
FDA 510(k)
FDA Class 2
·Cardiovascular
HHM
FDA UDI
Oticon A/S·05707131280114·H110, DESIGNRITE 10 WL SOR HHM
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·January 7, 2002
PATCH, PLEDGET AND INTRACARDIAC
FDA 510(k)
FDA Class 2
·Cardiovascular
REXEED SERIES DIALYZERS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 19, 2019
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·July 28, 2020
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·January 22, 2020
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013
PINN MAR NEUT 32IDX56OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·June 30, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 9, 2008
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016