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

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    FLEX-NAILS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Burn Relief - 18 Poly Navy

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588121611·Burn Relief - 18 Poly Navy

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033369807·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033369784·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033369821·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033369791·

    Cuff with connector

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904003948·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033369814·

    MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229

    FDA 510(k)
    FDA Unclassified ·Unknown

    STONE EXTRACTOR BALLOON CATHETER

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

    ECAREMANAGER V3.6

    FDA Adverse Event
    Malfunction ·VISICU·Product code MSX·September 21, 2009

    ECAREMANAGER V3.6

    FDA Adverse Event
    Malfunction ·VISICU·Product code MSX·December 14, 2009

    GORE® PROPATEN® VASCULAR GRAFT

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DSY·March 16, 2021

    EON

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 13, 2013

    BMWD 8X10 1 PACK

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES CORPORATION·Product code NAD·February 1, 2011

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 16, 2007

    GORE® PROPATEN® VASCULAR GRAFT

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DSY·May 19, 2021

    IV SET AN122 W/O PUMP T-TYPE

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·April 13, 2021

    Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules intended for use in todays growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 14, 2013

    UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025