7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0
FDA 510(k)
FDA Unclassified
·Unknown
MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EXPRT Revision Hip System - EXPRT Hip Distal Stem, EXPRT Hip Standard Offset Proximal Body Implant, EXPRT Hip Lateral Offset Proximal Body Implant, EXPRT Hip Capture Bolt
FDA 510(k)
FDA Class 2
·Orthopedic
LOGIC TIBIA PS MOD INSRT SZ 2 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 4, 2024
INRATIO2 PT/INR PROFESSIONAL TEST STRIP
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·May 30, 2014
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·February 13, 2013
STRKEFLOW2 WITHOUT TIP (6BX)
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY PUERTO RICO·Product code GCX·January 11, 2011