BEUDAMED
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    VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 28, 2020

    NXSTAGE PUREFLOW SOLUTION

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SPECIAL PROCEDURES HEAD COIL; MODEL # 1100GE-64

    FDA 510(k)
    FDA Class 2 ·Radiology

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 11, 2013

    MERIT CUSTOM KIT

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DTL·February 25, 2011

    CONTAK RENEWAL 3 RF HE

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012