BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    EPISTAXIS BALLOON CATHETER WITH PACKING

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    HI-TORQUE SPORT-T(TM) GUIDE WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    GORE TAG THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·November 4, 2011

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON , INC.·Product code FTL·February 6, 2013

    DISCOVERY II

    FDA Adverse Event
    Injury ·GUIDANT CLONMEL IRELAND·Product code NVZ·January 4, 2011

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·July 21, 2014

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·October 29, 2025

    PKG, PKG, HOOK SCISSORS, P/N 0250080260. 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