BEUDAMED
    19 results · 25ms · Sources: EU EUDAMED, US FDA

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    AFT SYSTEM PROFICIENCY TESTING PROGRAM

    FDA 510(k)
    FDA Class 2 ·Immunology

    MCOMPASS ANORECTAL MANOMETRY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    System, Rf/Microwave Hyperthermia, Cancer Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·BSD 1000 HYPERTHERMIA SYSTEM

    System, Rf/Microwave Hyperthermia, Cancer Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·BSD 1000 HYPERTHERMIA SYSTEM

    System, Rf/Microwave Hyperthermia, Cancer Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·BSD 1000 HYPERTHERMIA SYSTEM

    System, Rf/Microwave Hyperthermia, Cancer Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·BSD-500 HYPERTHERMIA SYSTEM

    System, Rf/Microwave Hyperthermia, Cancer Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·BSD-500 HYPERTHERMIA SYSTEM

    System, Rf/Microwave Hyperthermia, Cancer Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·BSD 1000 HYPERTHERMIA SYSTEM

    System, Rf/Microwave Hyperthermia, Cancer Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·BSD 1000 HYPERTHERMIA SYSTEM

    System, Rf/Microwave Hyperthermia, Cancer Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·BSD 1000 HYPERTHERMIA SYSTEM

    System, Rf/Microwave Hyperthermia, Cancer Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·BSD 1000 HYPERTHERMIA SYSTEM

    System, Rf/Microwave Hyperthermia, Cancer Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·BSD 1000 HYPERTHERMIA SYSTEM

    System, Rf/Microwave Hyperthermia, Cancer Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·BSD 1000 HYPERTHERMIA SYSTEM

    System, Rf/Microwave Hyperthermia, Cancer Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·BSD 1000 HYPERTHERMIA SYSTEM

    ESSURE

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC.·Product code HHS·May 16, 2014

    DLT TS CER HD 12/14 32MM +1

    FDA Adverse Event
    Injury ·DEPUY IRELAND - 9616671·Product code LZO·November 6, 2012

    PRIMA ESTH CON ZI ABUT RD 5.0X1.5MM

    FDA Adverse Event
    Malfunction ·KEYSTONE DENTAL·Product code NHA·August 24, 2010

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021