7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
DEFIBRILLATOR INTERAL PADDLE TEST LOAD
FDA 510(k)
FDA Class 2
·Cardiovascular
SunClear Aligner system
FDA 510(k)
FDA Class 2
·Dental
VALVED TEARWAY INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 5, 2014
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·October 15, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·August 2, 2007
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018