7 results
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17ms
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Sources: EU EUDAMED, US FDA
ISOFOR-MM (TM)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MAGNETOM Terra
FDA 510(k)
FDA Class 2
·Radiology
AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COOL PATH DUO 7F, 1304-CP2-7-1.5 (5)2-M-TE4BE1AB
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, IRVINE·Product code OAD·October 20, 2010
ENTERALITE INFINITY ENTERAL FEEDING PUMP
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code LZH·February 20, 2014
VA LOCKSCR Ø2.4 SELF-TAP L14 TAN
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HWC·December 21, 2012
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP 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