7 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS
FDA 510(k)
FDA Class 2
·General Hospital
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981497·anteriors; shade BL3; mould BIL2
OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS FIXATION DEVICE (MODEL OM-1503)
FDA 510(k)
FDA Class 2
·Orthopedic
HPM-6000UF
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ASCENDRA DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code NPT·February 27, 2013
GREENLIGHT HPS LASER SYSTEM
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·January 31, 2011
NA
FDA Adverse Event
Injury
·STRYKER SUSTAINABILITY SOLUTIONS LAKELAND·Product code NLQ·August 5, 2014