8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ROCHE SENSOR ADAPTOR
FDA 510(k)
FDA Class 2
·Anesthesiology
MARKSMANN CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UNKNOWN MICROCATHETER
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code DQY·May 30, 2017
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 6, 2014
EXTERNAL PULSE GENERATOR
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC.·Product code DTE·October 15, 2012
3" 1MM DEKOMPRESSOR KIT
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS PUERTO RICO·Product code HRX·July 27, 2010
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018