BEUDAMED
    22 results · 24ms · Sources: EU EUDAMED, US FDA

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    OES Elite Ureteroscopes and Accessories

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

    K-wire Sleeve

    FDA UDI
    Treace Medical Concepts, Inc.·00810111224567·3mm Short Sleeve

    Sonoma™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981050955·Sonoma Anterior Cervical Plate 3 Level Plate, 69mm

    Orthoquest

    FDA UDI
    Young Innovations, Inc.·00843471156766·Niti Thermal Multi-Force D-Form 020X020

    Manta Ray™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981057237·Plate - 3 Level - 69 mm

    ELECSYS ANTI-TG CALCHECK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5; VACUFLOW+ WITH HOLDER BLOOD COLLECTION SET, MODEL 82021/3/5 WITH HOLDER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 12, 2017

    ACRYSOF RESTOR

    FDA Adverse Event
    Other ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·October 10, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 1, 2013

    SUPER SHEATH

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·September 25, 2024

    SUPER SHEATH

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·July 13, 2023

    SUPER SHEATH

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·May 23, 2024

    SUPER SHEATH

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·June 7, 2024

    SUPER SHEATH

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·November 28, 2024

    SUPER SHEATH

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO., LTD.·Product code DRE·October 31, 2023

    SMR CEMENTLESS FINNED STEM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code HSD·February 12, 2024

    EMBLEM MRI S-ICD Model A219

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014