9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
LPM/50 MEMBRANE OXYGENATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
SleepmatePiezo Crystal Sensor & Band, Infant/Ped, Velcro Tab
FDA UDI
Ambu A/S·05707480041428·(Sleepmate item 1325)
SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PUREGRAFT 850/PURE SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TITAN TOUCH PUMP
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code FHW·May 15, 2018
MARYLAND BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·May 15, 2014
SPRINT QUATTRO
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·August 18, 2010
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018