7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODEL #100GE1500 LOWER EXTREM QUAD DETECT ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING
FDA 510(k)
FDA Class 3
·Cardiovascular
VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 21, 2010
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·January 29, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 15, 2014
EVOLUT FX DCS
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NPT·November 10, 2025