9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
RATEMINDER
FDA 510(k)
FDA Class 2
·General Hospital
ERA® Implant Abutment Standard 0°, 5mm Cuff (BF)
FDA UDI
STERNGOLD DENTAL LLC·00841549103148·Implant retained overdentures are an establishe...
BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STRATUS CS TROPONIN I CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HYDROPHILIC COATED CURE CATHETER WITH INSERTION KIT
FDA Adverse Event
Injury
·CURE MEDICAL LLC·Product code OHR·June 5, 2019
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 9, 2014
ADAPTA DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NVZ·October 31, 2012
PUMP MMT-522NAB PRDGM INS V2.2 BL 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