11 results
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26ms
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Sources: EU EUDAMED, US FDA
QUANTIMETRIC PLUS IGA REAGENT KIT
FDA 510(k)
FDA Class 2
·Immunology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209136629·
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837012014·
ARx SAI
FDA UDI
Life Spine, Inc.·00190837195618·
RABBIT-PERSONAL COMPUTER FOR WOMEN
FDA 510(k)
FDA Unclassified
·Unknown
EVANS, VAS-CATH EPIDURAL NEEDLE & CATHETER
FDA 510(k)
FDA Class 2
·Anesthesiology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 9, 2014
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code LHI·December 3, 2012
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code NAY·September 20, 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