BEUDAMED
    16 results · 23ms · Sources: EU EUDAMED, US FDA

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    Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)

    FDA 510(k)
    FDA Class 2 ·Radiology

    N/A

    FDA UDI
    PENTAX OF AMERICA, INC.·04961333242665·12 SDI TO SDI CABLE

    SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    COBAS INTEGRA ONLINE DAT II METHADONE II

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CAPTURE-R READY-ID EXTEND I

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·December 16, 2015

    REVERSE CON TWISTER

    FDA Adverse Event
    Malfunction ·C D REYNOSA·Product code KOC·November 5, 2008

    UNKNOWN 52MM PCA CUP

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·August 11, 2011

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·July 2, 2013

    MEDTRONIC LEAD

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DXY·July 16, 2025

    MEDTRONIC IPG

    FDA Adverse Event
    Death ·MEDTRONIC, INC.·Product code NVZ·July 16, 2025

    MEDTRONIC IPG

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code NVZ·July 16, 2025

    MEDTRONIC LEAD

    FDA Adverse Event
    Death ·MEDTRONIC, INC.·Product code DXY·July 16, 2025

    PANOSCREEN I AND II

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·December 22, 2015

    Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Product Usage: The device is used to perform Cardiopulmonary Resuscitation (CRP) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.

    FDA Enforcement
    Class III ·Terminated·Michigan Instruments, Inc.·May 16, 2018

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025