BEUDAMED
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    SonoSync

    FDA 510(k)
    FDA Class 2 ·Radiology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517631183·CoRoent Ant TLIF Ti, 14x11x30mm 12°

    LCP

    FDA UDI
    Synthes GmbH·10886982166715·3.5MM LCP® POSTEROLATERAL DSTL HUMERUS PL-LAT S...

    TOTAL MANDIBULAR SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036063238·

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517075342·

    REFUGE SOUND GENERATOR

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

    VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA)

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD INSYTE AUTOGUARD

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·August 22, 2024

    BD INSYTE AUTOGUARD

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·August 20, 2024

    BD INSYTE AUTOGUARD

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·August 21, 2024

    ANGIO-SEAL STS PLUS DEVICE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code MGB·November 20, 2008

    THERMAL LIGATING SHEARS

    FDA Adverse Event
    Malfunction ·STARION INSTRUMENTS·Product code GEI·August 19, 2011

    EMAX 2 PLUS MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 22, 2013

    BELLATEK HYBRID BAR 4 IMPLANTS

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·December 26, 2024

    BELLATEK HYBRID BAR 4 IMPLANTS

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·January 6, 2025

    BELLATEK¿ HYBRID BAR 5 IMPLANTS

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·February 18, 2025

    BELLATEK HYBRID BAR 5 IMPLANTS

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·March 18, 2025

    BELLATEK HYBRID BAR 4 IMPLANTS

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·January 6, 2025

    ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms associated with pleural effusions.

    FDA Enforcement
    Class II ·Terminated·Pfm Medical Inc·December 17, 2014

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014