BEUDAMED
    13 results · 18ms · Sources: EU EUDAMED, US FDA

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    MARLOW ANAL SPECULUM

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    binx health io CT/NG Assay

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESOLUTE INTEGRITY RX

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NIQ·June 24, 2014

    AFFINITY 4

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code HDD·November 2, 2010

    COMPANION EXTERNAL BATTERY

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, INC.·Product code LOZ·November 29, 2012

    G7 DUAL MOBILITY LINER 46MM G

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWY·September 22, 2017

    ACT ARTIC E1 HIP BRG 28X46MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWY·September 22, 2017

    TM ACETABULAR REVISION SYSTEM ACETABULAR AUGMENT

    FDA Adverse Event
    Injury ·ZIMMER TMT·Product code JDI·September 19, 2017

    TM ACETABULAR REVISION SYSTEM, COLUMN BUTTRESS

    FDA Adverse Event
    Injury ·ZIMMER TMT·Product code LPH·September 19, 2017

    SURGICEL ABSORBABLE HEMOSTAT

    FDA Adverse Event
    Injury ·ETHICON SARL·Product code LMF·June 7, 2016

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    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