7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
AIA-PACK FT3 ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OLINDA EXM
FDA 510(k)
FDA Class 1
·Radiology
TURBIQUANT MYOGLOBIN
FDA 510(k)
FDA Class 2
·Immunology
EXTENSIBLE TITANIUM PARTIAL PROSTHESIS
FDA Adverse Event
Malfunction
·AUDIO TECHNOLOGIES SRL·Product code ETB·April 3, 2014
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code MUZ·December 21, 2010
C-QUR TACSHIELD
FDA Adverse Event
Injury
·ATRIUM MEDICAL CORP.·Product code FTL·January 2, 2013
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024