30 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module
FDA 510(k)
FDA Class 2
·Cardiovascular
16PW - Washington Gas - Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588014425·16PW - Washington Gas - Poly White
OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR
FDA 510(k)
FDA Class 2
·Anesthesiology
LIGHT-CURED ORTHODONTIC BAND CEMENT
FDA 510(k)
FDA Class 2
·Dental
ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code MIH·July 18, 2014
GORE VIABAHN ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code NIP·October 16, 2008
ADAPTA DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NVZ·August 11, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013
ALUMINUM HOHMANN RETRACTOR 35MM WIDTH
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code GAD·March 3, 2016
ONYX
FDA Adverse Event
Death
·COVIDIEN (IRVINE)·Product code MFE·November 2, 2016
ONYX
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code MFE·November 1, 2016
TALENT TAA
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·October 16, 2014
VALIANT STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·October 16, 2014
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·July 6, 2018
VALIANT CAPTIVIA
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·May 3, 2016
HEARTWARE VENTRICULAR ASSIST SYSTEM-PUMP
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·February 21, 2018
HEARTWARE VENTRICULAR ASSIST SYSTEM-PUMP
FDA Adverse Event
Death
·HEARTWARE, INC.·Product code DSQ·February 21, 2018
TALENT TAA STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·May 3, 2016
VALIANT STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·May 3, 2016
HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·November 6, 2019