11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VersaD Delivery Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
ARCOMXL POLYETHYLENE LINERS
FDA 510(k)
FDA Class 2
·Orthopedic
PRELUDE PLASTIC JACKETED GUIDE WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·August 10, 2015
HEMOSPHERE ALTA
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025
HEMOSPHERE ALTA
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code QAQ·August 20, 2025
HEMOSPHERE ALTA
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 10, 2014
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·September 9, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2013
HEMOSPHERE ALTA
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025