10 results
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25ms
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Sources: EU EUDAMED, US FDA
AML CALCAR FEMORAL PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
InFix®
FDA UDI
ZIMMER SPINE, INC.·00889024331792·
DiMIM® Mini-Twin® Brackets
FDA UDI
Ortho Organizers, Inc.·00190707083250·DiMIM® Mini-Twin® .022 LL3 -6T 3A 0O
PRE-CALIBRATED PIPETTES
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CANMED 101
FDA 510(k)
FDA Class 2
·Cardiovascular
8 FRENCH POWER PORT
FDA Adverse Event
Injury
·BARD·Product code LJT·June 10, 2014
NEW LIGASURE 5MM
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·October 15, 2010
TOTAL ASR FEM IMP SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·December 14, 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