8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
STOMACH EVACULATOR - EWALD STYLE
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
S80 IMPLANTABLE CARDIAC PACING LEAD
FDA 510(k)
FDA Class 3
·Cardiovascular
VITAPEP
FDA 510(k)
FDA Class 2
·Anesthesiology
CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code DYE·June 10, 2014
LIFEVEST WCD 3100 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·October 5, 2010
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code NVY·December 10, 2012
STERNAL ZIPFIX W/NEEDLE PEEK SINGLE PACK
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code JDQ·June 30, 2020
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024