8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SCANEL 100
FDA 510(k)
FDA Class 2
·Radiology
HEARTCARD, MODEL 5258
FDA 510(k)
FDA Class 2
·Cardiovascular
POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 23, 2014
EXTERNAL PULSE GENERATOR
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC.·Product code DTE·October 31, 2012
PD1400 DEFIBRILLATOR/PACEMAKER
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 9, 2010
Pipeline Flex Embolization Device
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021
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