10 results
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19ms
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Sources: EU EUDAMED, US FDA
DISPOSABLE MONOPLAR MEDDLE ELECTRODES
FDA 510(k)
FDA Class 1
·Neurology
CLEARVIEW HCG SERUM/URINE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HEPARIN CONTROLS, HIGH AND LOW
FDA 510(k)
FDA Class 2
·Hematology
HUDSON AQUAPAK 640 SW,650 ML W/040 ADAPTOR,INT
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTT·January 14, 2016
PERSONA CEMENTED TIBIAL BROACH INSERTER
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code JWH·June 12, 2014
MEDTRONIC INFUSE BONE GRAFT OR RHBMP2
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NEK·January 10, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·November 19, 2010
4.5MM VA-LCP CURVED CONDYLAR PLATE/16 HOLE/336MM/LEFT
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code JDP·October 2, 2015
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