BEUDAMED
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    FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE

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

    Bard® Center Entry Urine Meter Add-A-Foley Tray with Bard EZ-Lok® Sampling Port

    FDA UDI
    C. R. Bard, Inc.·00801741029097·Bard® Center Entry Urine Meter Add-A-Foley Tray...

    Greenwald Surgical Company, Inc.

    FDA UDI
    GRACE MANUFACTURING, INC.·10801334006983·BOVIE UNIVERSAL ADAPTER

    IMA Super-Slide Retractor Set

    FDA UDI
    KOROS U.S.A., INC.·10840199544612·IMA Super-Slide Retractor Set Consists of the F...

    ZAVATION

    FDA UDI
    Zavation LLC·00197157014896·TIGER 2 X-TAB DILATION TUBE #2

    ZAVATION DILATION TUBE

    FDA UDI
    Zavation LLC·00197157014889·TIGER 2 X-TAB DILATION TUBE #1

    ZAVATION DILATION TUBE

    FDA UDI
    Zavation LLC·00197157014902·TIGER 2 X-TAB DILATION TUBE #3

    POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    D R Burton OxyPAP

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 24, 2014

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 6, 2015

    MECHANICAL CHAIR/TRANSPORT CHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code INM·January 1, 2013

    COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE 36MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code PAO·April 27, 2017

    COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING STANDARD +3MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code PAO·April 27, 2017

    COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY 44MM STANDARD

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWS·April 27, 2017

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

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