BEUDAMED
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    OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160,

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

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756190824·SHOULDER BASIN SET

    POLINELLI

    FDA UDI
    FGX INTERNATIONAL INC.·00193033333327·

    POLINELLI

    FDA UDI
    FGX INTERNATIONAL INC.·00193033333358·

    POLINELLI

    FDA UDI
    FGX INTERNATIONAL INC.·00193033333419·

    POLINELLI

    FDA UDI
    FGX INTERNATIONAL INC.·00193033333334·

    POLINELLI

    FDA UDI
    FGX INTERNATIONAL INC.·00193033333341·

    SIMPLICITY WING INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    APEX FIXATION PINS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·January 24, 2017

    ULTRA-THIN SDS BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORP.·Product code DQY·December 8, 2006

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·February 9, 2011

    PUMP MMT-722NAS PRDGM INS V2.2. SK EN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·March 10, 2008

    UPHOLD LITE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OTP·December 11, 2018

    SPEEDBAND SUPERVIEW SUPER 7

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MND·August 3, 2022

    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