10 results
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18ms
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Sources: EU EUDAMED, US FDA
HICHEM BUN/UREA REAGENT KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Eye Shield
FDA UDI
KATENA PRODUCTS, INC.·00841668111147·FOX EYE SHIELD W/ GARTER PED PACK OF 50
HA Bone Screws
FDA UDI
ORTHOFIX SRL·18032568861754·OSTEOTITE BONE SCREW 200/50 MM SHAFT D 6 MM TH...
DIGILAB CAMBRIDGE PERIMETER
FDA 510(k)
FDA Class 1
·Ophthalmic
Heat Pain Pro
FDA 510(k)
FDA Class 2
·Neurology
BOM 7MM EXTENDED LENGTH ENDOSCOPE
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GCJ·June 23, 2014
COULTER® LH 500 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·February 13, 2013
CENTRA BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·December 17, 2010
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