7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)
FDA 510(k)
FDA Class 1
·Ophthalmic
AMSURE BLADDER IRRIGATION SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl
FDA 510(k)
FDA Class 2
·Dental
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 21, 2013
MAVERICK2 BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·January 26, 2011
VNGD CR TIB BRG 12X63/67
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·July 31, 2014
InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294.
FDA Recall
Terminated
·Intervascular S.A.S. Zone Industrielle Athelia I La Ciotat Cedex France·Product code DSY·December 9, 2009