11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HOWMEDICAL TOTAL KNEE STEM EXTENDER
FDA 510(k)
FDA Class 2
·Orthopedic
STAT.BR TM
FDA 510(k)
FDA Class 2
·Dental
STOMA MEASURING DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DHS/DCS COUPLING SCREW
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code JDO·January 22, 2013
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·December 7, 2010
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 9, 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