8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CCS POLYSAFE(TM) ENDOCARDIAL PACING LEAD
FDA 510(k)
FDA Class 3
·Cardiovascular
AVL MODEL 945 BLOOD GAS SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
UNSCENTED MENSTRUAL PAD
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES LLC·Product code DYE·June 30, 2025
CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·June 10, 2014
INRATIO2
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·October 5, 2010
OASYS POLYAXIAL SCREW CANCELLOUS DIA 3.5 X 16
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code NKB·December 6, 2012
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024