10 results
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19ms
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Sources: EU EUDAMED, US FDA
PROCEL BURN COVER
FDA 510(k)
FDA Unclassified
·Unknown
Genesis
FDA UDI
KEYSTONE DENTAL, INC.·D768K156950·Ratchet
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100622·KATENA DOUBLE-X SPECULUM V-WIRE
MICRO-X 80HF
FDA 510(k)
FDA Class 1
·Radiology
AUTO SASH (TM)
FDA 510(k)
FDA Class 2
·General Hospital
PULSE GEN MODEL 104
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·July 15, 2015
BARD PLATINUM CLASS FLAT WIRE STONE BASKET
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (COVINGTON)·Product code FFL·June 12, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·January 15, 2013
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