6 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA
FDA 510(k)
FDA Class 2
·Hematology
AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1
FDA 510(k)
FDA Class 1
·Clinical Chemistry
INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450
FDA 510(k)
FDA Class 2
·Cardiovascular
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 28, 2013
INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·December 16, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 12, 2014