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

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    MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450536742·

    REXIOUS HOOK FIXATION SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HPI SENSI GRIP STERILE POWDERED LATEX SURGICAL GLOVE,WITH LABELED PROTEIN CONTENT AND MADE FROM ALLOTEX AN ENZYME TREAT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    VISCOUS-SPRAY APPLICATOR W/3CM MXING TIP

    FDA Adverse Event
    Malfunction ·MICROMEDICS, INC.·Product code KYZ·January 8, 2013

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·November 11, 2010

    EMAX 2 MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 3, 2014

    PKG, BIPOLAR FORCEPS, PADDLE, 33CM, P/N 0250080361. 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

    PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013