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

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    AMPLIVUE GAS ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CHORD-X EPTFE SUTURE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996

    FDA 510(k)
    FDA Class 2 ·Immunology

    VIDAS HCG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code JLW·November 26, 2020

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·October 3, 2014

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 24, 2013

    IAB : 8 FR - 30 CC FOS

    FDA Adverse Event
    Injury ·ARROW INTL., INC.·Product code DSP·June 22, 2011

    VIDAS TSH

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code JLW·November 25, 2020

    VIDAS HCG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code JHI·August 19, 2021

    StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.

    FDA Enforcement
    Class II ·Terminated·Dental EZ Stardental Division·June 19, 2013

    PKG, ATRAUMATIC FORCEPS, SINGLE ACTION, P/N 0250080310. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018