BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    CD HORIZON Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LOW ADHERENT AFM AG DRESSINGS

    FDA 510(k)
    FDA Unclassified ·Unknown

    MICROLIFE DUAL MODE THERMOMETER,MODEL IFR1MJ1

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 30, 2015

    VICTORY XL DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CRMD·Product code DXY·January 13, 2014

    PELVICOL 2CM X 7CM 1.0MM

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TISSUE·Product code FTL·May 24, 2013

    SOFTHEAT

    FDA Adverse Event
    Other ·KAZ INC·Product code IRT·June 21, 2011

    FREESTYLE LIBRE 2

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code QLG·May 18, 2026

    PKG, 3MM INSERT, DORSEY GRASPER, 29CM, P/N 0250282097 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Nebion H LX-8 magnetic resonance device and stand. Most devices, as they are prototypes, have no labeling, If they are labeled, it is simply as Nebion H LX-8

    FDA Recall
    Terminated ·Nebion, LLC·June 25, 2008

    Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025