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

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    FRINDLEY ENTERPRISE CO

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    QUALITY REPORTS

    FDA 510(k)
    FDA Class 2 ·Radiology

    RUNWAY GUIDE CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·May 8, 2013

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·December 28, 2012

    PROXIMAL INTRAPHARANGEAL JOINT TRIAL

    FDA Adverse Event
    Malfunction ·ASCENSION ORTHOPEDICS, INC.·Product code MPK·November 15, 2010

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·July 17, 2014

    PKG, 5MM X 33CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, P/N 0250080757 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