BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

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    I/A HANDPIECE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756712903·EXTREMITY/SCOPE PACK

    DC-4 SHUNT INFUSION T

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

    SPORVIEW CULTURE MEDIA

    FDA 510(k)
    FDA Class 2 ·General Hospital

    QUALA DENTAL PRODUCTS

    FDA Adverse Event
    Malfunction ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAL·August 31, 2011

    ACE

    FDA Adverse Event
    Malfunction ·SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)·Product code GAL·August 30, 2010

    HU-FRIEDY PERMA SHARP SUTURES

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAL·June 2, 2010

    UNKNOWN SALINE IMPLANTS

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·May 13, 2024

    UNKNOWN SALINE IMPLANTS

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·May 13, 2024

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·May 20, 2014

    TENDRIL SDX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2010

    L9000 LIGHT SOURCE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·November 21, 2012

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015