8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SYNERGY II
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT
FDA 510(k)
FDA Class 2
·Radiology
PINPOINT GT SAFETY INTRODUCER NEEDLE
FDA 510(k)
FDA Class 2
·Cardiovascular
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·February 4, 2013
OPTA PRO PTA DILATATION CATHETER
FDA Adverse Event
Malfunction
·CORDIS EUROPA, N.V.·Product code LIT·December 30, 2010
2.3MM X 18MM LOCKING CORTICAL SCREW
FDA Adverse Event
Injury
·ACUMED LLC·Product code HRS·July 17, 2014
OT SURESTEP METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·December 6, 2010
DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)
FDA Enforcement
Class I
·Terminated·Synthes, Inc.·August 27, 2014