BEUDAMED
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    SUPERSTAR 0.35T MRI SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    NA

    FDA UDI
    KEY SURGICAL, INC.·10849771049118·K-Wires, Single trocar, .054-inch (1.4mm) diame...

    Key Surgical K-Wires and Steinmann Pins

    FDA UDI
    KEY SURGICAL, INC.·00849771012535·K-Wires, Single trocar, .054-inch (1.4mm) diame...

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704292770·

    Prosthesis Head Large

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575993338·Prosthesis Head,

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 2, 2024

    ELIPAR FREELIGHT

    FDA 510(k)
    FDA Class 2 ·Dental

    I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    COTTON TIPPED APPLICATOR, 6 INCH

    FDA Adverse Event
    Malfunction ·CITMED CORPORATION·Product code KXG·April 8, 2013

    VANGUARD INSTRUMENTS PS BOX REAMER 62.5 - 67.5MM

    FDA Adverse Event
    Malfunction ·BIOMET ORTHOPEDICS·Product code HTO·April 27, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEM INC.·Product code JAA·July 10, 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

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022