11 results
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18ms
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Sources: EU EUDAMED, US FDA
CUDDLE CAP
FDA 510(k)ERA® Implant Abutment Micro Ang. Base, 5mm Cuff (BF)
FDA UDI
STERNGOLD DENTAL LLC·00841549102974·Implant retained overdentures are an establishe...
LEONE SPA
FDA UDI
LEONE SPA·08033707008330·STRAIGHT WIRES EXTRA SPRING HARD 16x22
Perfect Fit
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377021527·Perfect Fit™ II R/S Pediatric Kit includes: 2- ...
BD PERFUSION¿ SYRINGE W/NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·April 25, 2019
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 9, 2014
SPRINT
FDA Adverse Event
Injury
·MPRI·Product code LWS·October 31, 2012
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 2, 2015
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