11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AGILON® XO Shoulder Replacement System
FDA 510(k)
FDA Class 2
·Orthopedic
DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)
FDA 510(k)
FDA Class 2
·Dental
HOME ACCESS AIC TEST
FDA 510(k)
FDA Class 2
·Hematology
NEXUS AND NXT DETACHABLE COIL
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code HCG·March 17, 2009
BARDWIL DOUBLE-ENDED PHLEBECTOMY AND SPATULA
FDA Adverse Event
Malfunction
·TOTAL VEIN SYSTEMS·Product code GDG·November 17, 2008
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Malfunction
·KANAE CO.,LTD.·Product code KDI·September 9, 2011
TOTAL ASR ACET IMP SIZE 58
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·July 22, 2013
NEXUS AND NXT DETACHABLE COIL
FDA Adverse Event
Malfunction
·EV3 NEUROVASCULAR·Product code HCG·April 21, 2009
LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
FDA Adverse Event
Malfunction
·REYNOSE MANUFACTURING·Product code FKX·August 19, 2011
BD VACUTAINER PPT PLASMA PREPARATION TUBE K2E 9.0 MG
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·May 4, 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