8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
ENDOSCOPIC SCLEROTHERAPY BALLOON
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE
FDA 510(k)
FDA Class 2
·General Hospital
GRIPPER PLUS NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 20, 2014
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code GJS·October 1, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·September 1, 2010
AIM-ARM F/PHILOS 3.5
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code FZX·June 8, 2018
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