BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    FREEPRINT crown

    FDA 510(k)
    FDA Class 2 ·Dental

    RANGE SPINAL SYSTEM, SMALL STATURE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OBSERVER ULTRASOUND REPORTING AND IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    PROLIEVE THERMODILITATION KIT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·November 6, 2008

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·August 10, 2011

    ADVIA 120

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code GKL·July 12, 2013

    TEMA ELBOW SYSTEM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code JDB·September 26, 2024

    MEDTRONIC LEAD

    FDA Adverse Event
    Death ·MEDTRONIC, INC.·Product code DXY·April 28, 2026

    MEDTRONIC ICD

    FDA Adverse Event
    Death ·MEDTRONIC, INC.·Product code DXY·April 28, 2026

    MEDTRONIC LEAD

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DXY·April 29, 2026

    MEDTRONIC ICD

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DXY·April 28, 2026

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 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

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025