11 results
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28ms
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Sources: EU EUDAMED, US FDA
EM-X
FDA 510(k)
FDA Class 2
·Hematology
ERA® Implant Abutment Micro 0°, 5mm Cuff (BF)
FDA UDI
STERNGOLD DENTAL LLC·00841549103032·Implant retained overdentures are an establishe...
SUNTANNING DEVICE (SEPAR. FROM K812225)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD PLASTIPAK 50ML LUER-LOK SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·April 11, 2019
Soniquence Reusable 3 Button Fingerswitch Wand
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ALCATRON AND / OR MULTIPLE BRAND
FDA 510(k)
FDA Class 1
·General Hospital
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 9, 2014
SPRINT FIDELIS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·August 20, 2010
8110 ALARIS SYRINGE PUMP
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 28, 2020
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