8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
H BROTH
FDA 510(k)
FDA Class 1
·Microbiology
Tranquil-L™
FDA UDI
NEXUS SPINE, L.L.C.·B6788230910·17mm - Trial Distractor, 18 Deg
VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T
FDA 510(k)
FDA Class 2
·Radiology
ST AIA-PACK TESTOSTERONE ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PRIME CARE (R) B900
FDA Adverse Event
Malfunction
·PRIMUS MEDICAL LLC·Product code FNL·January 20, 2014
UNKNOWN DEPUY ASR ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 7, 2012
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 6, 2015
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015