BEUDAMED
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    xvision Spine System

    FDA 510(k)
    FDA Class 2 ·Neurology

    IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 16MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·September 9, 2022

    MODEL BBC-127 BIOPSY BREAST COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRC-NW400 NON-MYDRIATIC RETINAL CAMERA

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 16MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·June 30, 2022

    IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 16MM

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code DZE·August 26, 2021

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 10, 2014

    HEARTSTART MRX -EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·August 9, 2011

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·July 22, 2013

    PKG, CLAW FORCEPS, P/N 0250080244. 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