7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
ACID PHOSPHATASE REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EK/P. AERUGINOSA PNA FISH
FDA 510(k)
FDA Class 1
·Microbiology
GIGANTOS 1012 MP
FDA 510(k)
FDA Class 1
·Radiology
CARPENTIER-EDWARDS PERIMOUNT® PLUS PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·June 24, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·November 3, 2010
DEXTRUS 4137
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG.·Product code NVZ·December 18, 2012
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024