9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
OPUS MYOGLOBIN CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
P.F.C. SIGMA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295244844·P.F.C. SIGMA STABILIZED PLUS TIBIAL INSERT TRIA...
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY PLATES
FDA 510(k)
FDA Class 2
·Microbiology
VariAx Distal Radius Plating System, VariAx 2 System
FDA 510(k)
FDA Class 2
·Orthopedic
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code NPT·February 14, 2013
TIBIAL ALIGNMENT HANDLE
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·December 22, 2010
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code FPA·July 29, 2014
CONTOUR ACETABULAR RECONSTRUCTION RING
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDJ·June 6, 2025
MESH, SURGICAL, ACETABULAR, HIP, PROSTHESIS
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDJ·January 23, 2026