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

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    Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Vanguard® Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304271913·

    Best Medical International

    FDA UDI
    BEST MEDICAL INTERNATIONAL, INC.·00841365114199·

    2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·April 26, 2022

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·October 4, 2008

    DIMENSION XPAND PLUS WITH HM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code MMI·June 22, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 29, 2011

    DIAMONDBACK CORONARY

    FDA Adverse Event
    Injury ·CARDIOVASCULAR SYSTEMS, INC.·Product code MCX·October 10, 2024

    PHOTOFIX PATCH - 6CM X 8CM

    FDA Adverse Event
    Injury ·CRYOLIFE, INC. - KENNESAW·Product code PSQ·January 12, 2021

    BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, and PAK6455 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·January 13, 2016