29 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ceribell Instant EEG Headband
FDA 510(k)
FDA Class 2
·Neurology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526159860·PROTECT.ACHI ANKLE SUPPORT GRAY V
Zavation
FDA UDI
Zavation LLC·00842166132412·Ti3Z CIF 13mmx15mmx5mm -8 deg
ZAVATION
FDA UDI
Zavation LLC·00842166104501·CIF 13x15, 8 deg, -05
9616240-2006-00344
FDA Adverse Event
Malfunction
·Product code KDI·June 14, 2006
9616240-2006-00342
FDA Adverse Event
Malfunction
·Product code KDI·June 14, 2006
9616240-2006-00330
FDA Adverse Event
Malfunction
·Product code FII·June 1, 2006
PRISMA SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)
FDA 510(k)
FDA Class 2
·Orthopedic
9616240-2006-00349
FDA Adverse Event
Malfunction
·Product code FII·June 21, 2006
9616240-2006-00348
FDA Adverse Event
Malfunction
·Product code FDI·June 20, 2006
*
FDA Adverse Event
Malfunction
·Product code FII·June 1, 2006
BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE 30G X 5MM
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·July 15, 2016
9616240-2006-00346
FDA Adverse Event
Malfunction
·Product code FII·June 14, 2006
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - MAHWAH·Product code DSP·January 12, 2023
BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE 30GX5MM
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·August 16, 2016
VITALITY DS
FDA Adverse Event
Death
·CLONMEL·Product code LWS·October 23, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011
TRUEBALANCE
FDA Adverse Event
Other
·NIPRO DIAGNOSTICS, INC.·Product code NBW·July 2, 2013
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025