11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POLY-DIAL INSERTS
FDA 510(k)
FDA Class 2
·Orthopedic
HIGH VAC
FDA 510(k)
FDA Class 1
·Dental
GASTROINTESTINAL TUBE AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DRILL BIT Ø1 L50/35
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HTW·January 22, 2013
TALENT THORACIC STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·December 7, 2010
UNKNOWN DEPUY FEMORAL STEM
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC. - 1818910·Product code KWA·July 10, 2014
SWAN-GANZ CONTINUOUS CARDIAC CATHETER
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES, PR·Product code KRA·November 11, 2011
SWAN-GANZ CONTINUOUS CARDIAC CATHETER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code KRA·November 11, 2011
SWAN-GANZ CONTINUOUS CARDIAC CATHETER
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES, PR·Product code KRA·November 11, 2011
SWAN-GANZ CONTINUOUS CARDIAC CATHETER
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES, PR·Product code KRA·November 11, 2011
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024