8 results · 19ms · Sources: EU EUDAMED, US FDA

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EA 50

FDA 510(k)
FDA Class 1 ·Hematology

16PW - Genesee & Wyoming RR - Poly White

FDA UDI
Certified Safety Manufacturing, Inc.·00766588120874·16PW - Genesee & Wyoming RR - Poly White

TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS

FDA 510(k)
FDA Class 2 ·General Hospital

CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 15, 2014

CAPSUREFIX NOVUS MRI

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code NVN·October 31, 2012

7900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·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