BEUDAMED
    188 results · 26ms · 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.

    TARGET ASO TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Grasping forceps

    FDA UDI
    SOPRO-COMEG GmbH·04059082021959·

    Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPLINE DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    MEGADYNE ACE BLADE 700M ZIP E

    FDA Adverse Event
    Malfunction ·MEGADYNE MEDICAL PRODUCTS, INC.·Product code GEI·March 16, 2023

    COAGUCHEK® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·November 30, 2010

    INSIGNIA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·January 11, 2013

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·July 2, 2014

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ENDOTAK LEAD SYSTEM

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ENDOTAK RELIANCE/RELIANCE S ENDOCARDIAL DEFIBRILLATION LEADS

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·RELIANCE IS-4 DEFIBRILLATION LEAD

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ENDOTAK RELIANCE Leads

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·RELIANCE LEADS

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·ENDOTAK RELIANCE IS-I PASSIVE FIXATION

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·IS-1 CONNECTOR TERMINAL MODEL 6952 LEAD EXTENDER

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Endotak Lead System

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ENDOTAK LEAD SYSTEM

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ENDOTAK RELIANCE S RX IS-1/EZ IS-1/4-SITE EZ/4-SITE RX LEADS

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ENDOTAK(R) SQ LEAD ARRAY MODEL 0048

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ENDOTAK RELIANCE IS-1 AND ENDOTAK RELIANCE 4-SITE LEAD MODELS