8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TEMPORARY PACEMAKER ELECTRODE
FDA 510(k)
FDA Class 2
·Cardiovascular
Focal 44 Sublative iD, (20 Pulse), 10-Pk
FDA UDI
SYNERON MEDICAL LTD·37290109951202·Focal 44 Sublative iD, (20 Pulse), 10-Pk
Wrist Type Automatic Blood Pressure Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDSTREAMING MEDICAL OFFICE SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·June 13, 2014
COLLEAGUE CXE VOLUMETRICINFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 18, 2010
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·December 13, 2012
V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·October 19, 2016