8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
DILUENT
FDA 510(k)
FDA Class 1
·Hematology
COLONGLIDE(R) LUBRICANT
FDA 510(k)
FDA Class 1
·General Hospital
MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN
FDA 510(k)
FDA Class 3
·Cardiovascular
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 26, 2014
RELIANCE 777 WASHER
FDA Adverse Event
STERIS CANADA CORPORATION·Product code LDS·November 14, 2012
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code LWP·June 10, 2015
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018