10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SPECTRO FEIRITIN
FDA 510(k)
FDA Class 2
·Immunology
Preat
FDA UDI
Preat Corporation·00842092127834·Sphero Block Abutment Straumann BL NC x 1mm (2....
Bioplate®
FDA UDI
Bioplate, Inc.·M3848120560·Rigid Burr Hole Cover - Ø1.5 mm - 6 hole - 18 mm
EZout
FDA UDI
STRYKER CORPORATION·07613327294484·Blade Pack, 56mm
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HOMECHOICE
FDA Adverse Event
Death
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 15, 2014
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·October 31, 2012
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 17, 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