BEUDAMED
    14 results · 29ms · Sources: EU EUDAMED, US FDA

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    HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sportex

    FDA UDI
    Diversified Products, Inc.·00037741405054·

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690199540·Modular Knee Straight Reamer - 22mm

    MESA® Small Stature Spinal System

    FDA UDI
    VB Spine LLC·10888857046481·Deformity Polyaxial Screw Size Ø5.0x22.5 mm

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0602250·Tray, Base, 2.25"

    DOSIMETRY CHECK

    FDA 510(k)
    FDA Class 2 ·Radiology

    CARD GUARD PERSONAL ELECTROCARDIOGRAM TRANSMITTER, MODEL CG-6206/6306

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 6, 2025

    RD SET GE - 12

    FDA Adverse Event
    Malfunction ·Product code DQA·August 13, 2021

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·September 17, 2013

    GREENLIGHT HPS LASER SYSTEM

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS·Product code GEX·April 5, 2013

    ALTRUA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·April 12, 2011

    WINGSPAN STENT SYSTEM

    FDA Adverse Event
    Injury ·NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION·Product code NJE·May 22, 2008

    Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.

    FDA Enforcement
    Class II ·Terminated·Ace Surgical Supply Co., Inc.·May 2, 2018