9 results
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33ms
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Sources: EU EUDAMED, US FDA
EAGLE 2000 STERILIZER SERIES GAS/AERA
FDA 510(k)
FDA Class 2
·General Hospital
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172971109·
CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
SIMPLEX X
FDA 510(k)
FDA Class 2
·Orthopedic
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 17, 2014
UNKNOWN DEPUY POLY LINER
FDA Adverse Event
Injury
·Product code KWA·November 15, 2012
BASAL/BOLUS INFUSOR 2ML X 2ML6 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·September 13, 2010
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017