8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
RESPIRATORY SYNCYTIAL VIRUS ID REAGENT
FDA 510(k)
FDA Class 1
·Microbiology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209122189·
Biomet Spine Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
LigaMend
FDA 510(k)
FDA Class 2
·Orthopedic
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 6, 2014
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·December 3, 2012
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·September 30, 2010
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024