BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    Phenom 27 Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515023789·Ribbon Retractor, 5/8" Width, 8"

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970362·

    LAG SCREW, TI GAMMA3 10.5X95MM

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 25, 2012

    SPECIMEN RETRIEVAL SYSTEM

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

    DORNIER MEDILAS D 30 LASER, MEDILAS D 1064

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 10, 2014

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code ITJ·June 20, 2013

    UNICEL DXC 800 SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code CGA·July 1, 2011

    SenTec Standard Starter Set with and without Service Gas (2 changers each) - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.

    FDA Enforcement
    Class II ·Terminated·SenTec AG·August 14, 2019