9 results
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26ms
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Sources: EU EUDAMED, US FDA
OMIBAND
FDA 510(k)
FDA Class 1
·General Hospital
EDENTA
FDA UDI
EDENTA ETABLISSEMENT·E312K90044510001·Dowel Pin 15 mm
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515230682·Perkins Oto, right,5 1/4"
OLYMPIC BILI-METER(TM) WITH TYPE-F SENSOR
FDA 510(k)
FDA Class 2
·General Hospital
LYMPHO SEP(TM)
FDA 510(k)
FDA Class 1
·Hematology
STRYKER GO BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·November 30, 2012
COBAS 6000 E601 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·July 1, 2014
HS HAND CONTROLLED CURVED SHEA
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code LFL·February 8, 2008
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF 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