8 results · 21ms · Sources: EU EUDAMED, US FDA

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Cardiac Guidance

FDA 510(k)
FDA Class 2 ·Radiology

CERTAIN GOLD-TITE HEXED SCREW

FDA Adverse Event
Malfunction ·BIOMET 3I·Product code NHA·May 21, 2021

NuVasive ALIF Buttress Plate System

FDA 510(k)
FDA Class 2 ·Orthopedic

VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P

FDA 510(k)
FDA Class 2 ·Cardiovascular

UNKNOWN DEPUY ELBOW PIN ASSEMBLY

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDC·November 21, 2008

DURATA STS OPTIM ACTIVE FIXATION

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011

HEARTSTART FRX

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 18, 2013

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