7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PHILIPS URO DIAGNOST MRF
FDA 510(k)
FDA Class 2
·Radiology
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN
FDA 510(k)
FDA Class 2
·Radiology
CUSA EXCEL CONSOLE
FDA Adverse Event
Malfunction
·VALLEYLAB·Product code ---·April 2, 2007
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
BECKMAN COULTER INC.·Product code JJE·November 30, 2010
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Death
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·July 2, 2014
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024