7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MODIFIED GELMAN ARTERIAL FILTER
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IMPLANTABLE ENDOCARDIAL TINED ELECTRODE
FDA 510(k)
FDA Class 3
·Cardiovascular
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·June 24, 2014
F/G GATEWAY OTW US 9 X 2.5
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MINN·Product code GBA·January 2, 2013
LIBERTY CYCLER SET, DUAL PATIENT CONNECT
FDA Adverse Event
Injury
·REYNOSA MANUFACTURING·Product code FKX·October 28, 2010
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