8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
STREPTOCOCCUS ID TRIPLATE SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
FORTE GAMMA CAMERA SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
REVLITE Q-SWITCHED ND:YAG LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OPTIBOND XTR
FDA Adverse Event
Injury
·KERR CORPORATION·Product code KLE·May 27, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 15, 2012
UNKNOWN DEPUY ENDURANCE CEMENT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDG·September 9, 2010
Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi cobas c systems.
FDA Recall
Terminated
·Roche Diagnostics Corporation·Product code CJW·March 18, 2019
cobas e 801 immunoassay analyzer
FDA Recall
Terminated
·Roche Diagnostics Corporation·Product code JJE·March 15, 2019