7 results
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35ms
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Sources: EU EUDAMED, US FDA
SPOTTEST ACRIDINE ORANGE STAIN
FDA 510(k)
FDA Class 1
·Microbiology
ICEROD CX CRYOABLATION NEEDLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NMX-1000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 30, 2014
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 20, 2012
REVOLUTION CEMENT GUN
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code JDZ·June 12, 2015
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