9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)
FDA 510(k)
FDA Class 2
·Radiology
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·April 16, 2020
O-MAR
FDA 510(k)
FDA Class 2
·Radiology
VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·January 3, 2011
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·November 11, 2014
CURLIN INFUSION PAINSMART IOD IV PUMP
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code FRN·September 1, 2011
MONARCH CAP INSERTER, SHORT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code LXH·July 23, 2013
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