11 results
·
28ms
·
Sources: EU EUDAMED, US FDA
STREP A NEGATIVE CONTROL
FDA 510(k)
FDA Class 1
·Microbiology
METER TRAX
FDA 510(k)
FDA Class 2
·Hematology
A-V IMPULSE SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
S-ROM*SLEEVE PRX ZTT, 16F-XXL
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code MRA·January 22, 2013
OMNISPAN 12 DEGREE MENISCAL FASTENER
FDA Adverse Event
Injury
·DEPUY MITEK·Product code MBI·December 7, 2010
ASR UNI FEMORAL IMPL SIZE 45
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·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