8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT
FDA 510(k)
FDA Class 2
·Immunology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209122325·
EXTRA SENSORY PAK-DISPOS. ACCESS
FDA 510(k)
FDA Class 2
·Ophthalmic
PREP TYPE A EXTRACTION CARTRIDGE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 6, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·December 3, 2012
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·September 29, 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