18 results
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34ms
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Sources: EU EUDAMED, US FDA
EMIT CHLORAMPHENICOL ASSAY/BI-LEVEL CONTROLS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837013011·
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837013042·
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837013073·
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837013028·
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837013035·
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837013080·
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837013059·
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837013066·
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837013004·
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837013097·
OSTEOBOOST-BMA
FDA 510(k)
FDA Class 2
·General Hospital
VASCULAR CATHETER WIREGUIDES
FDA 510(k)
FDA Class 2
·Cardiovascular
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·June 10, 2014
ENDOPATH** ETS FLEX45
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·December 7, 2012
FREESTYLE NAVIGATOR
FDA Adverse Event
Injury
·Product code LFR·October 8, 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