8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
ERYPUR B
FDA 510(k)
FDA Class 2
·General Hospital
CHURCHILL-HE VENTED IV SET
FDA 510(k)
FDA Class 2
·General Hospital
SENTRY SIGNAL ENURESIS ALARM SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SUMMIT POR TAPER SZ4 STD OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·June 10, 2014
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 12, 2010
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·November 8, 2012
Presource PBDS, Shoulder Procedure, Kit, Circulator
FDA Enforcement
Class I
·Terminated·Cardinal Health, Medical Products & Services·May 15, 2013
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024