8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
SONIK MONARK 100
FDA 510(k)
FDA Unclassified
·Unknown
Neutral
FDA UDI
Sbo Hearing A/S·05714464034697·Oasisnxt Custom 2022.1.0
MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055
FDA 510(k)
FDA Class 2
·Cardiovascular
WAVETRONIC 5000 DIGITAL HF SURGICAL UNIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OT VERIO SYNC METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 7, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·August 29, 2011
ENTERPRISE 9000
FDA Adverse Event
Malfunction
·ARJO, INC.·Product code FNL·July 11, 2013
ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 22, 2020