7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
DYNA TRAK ENDODONTIC PREP. INSTRUMENT
FDA 510(k)
FDA Class 1
·Dental
WIENER LAB. UREA UV CINETICA AA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PALACOS MV
FDA 510(k)
FDA Class 2
·Orthopedic
LASSO® 2515 NAV ECO VARIABLE CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·May 15, 2014
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012
PUMP MMT-522NAP PRDGM INS V2.2 PL EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·August 20, 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