BEUDAMED
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    PeriCross™ Epicardial Access Kit

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu

    FDA 510(k)
    FDA Class 2 ·Dental

    BIOFIRE SPOTFIRE Respiratory (R) Panel

    FDA 510(k)
    FDA Class 2 ·Microbiology

    INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·November 11, 2014

    STERIS 5085 GENERAL SURGICAL TABLE

    FDA Adverse Event
    Injury ·STERIS CORP.·Product code FQO·September 6, 2011

    CADIERE FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code GCJ·July 23, 2013

    PKG, GRASPER FORCEPS, SERRATED, P/N 0250080286. 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