BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    MTP E.V. INFUSION PUMP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TECHFIT DISRP® System

    FDA 510(k)
    FDA Class 2 ·Dental

    Applanation Tonometer

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 21, 2012

    PKS PLASMA MORCELLATOR

    FDA Adverse Event
    Injury ·GYRUS ACMI INC·Product code HET·June 12, 2015

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code MGB·September 18, 2010

    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