10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QUANTIMETRIC PLUS KAPPA REAGENT KIT
FDA 510(k)
FDA Class 2
·Immunology
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837015879·
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837012007·
BIO-BAG ENVIRONMENTAL CHAMBER -TYPE A-MULTI-PLATE
FDA 510(k)
FDA Class 1
·Microbiology
SOPHEIA/MP CORTISOL EIA KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 9, 2014
CAPSURE SENSE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 5, 2010
UNKNOWN OPTEASE VENA CAVA FILTER
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code DTK·December 3, 2012
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