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

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    BREAST LESION LOCALIZATION NEEDLE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    UNIVERSAL COMPRESION SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MULTIPLE IMAGING XENON ARC AUTO LIGH SOURCE

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

    SPIROBAC FILTER REINF MEMBRANE

    FDA Adverse Event
    Malfunction ·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code CAH·August 1, 2012

    MULTI-LUMEN/PSI KIT: 9 F R DISTAL X 4-1/2

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code FOZ·January 31, 2013

    SENSOR ENLITE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·July 18, 2014

    COULTER® LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·January 3, 2011

    PKG, ATRAUMATIC FORCEPS, SINGLE ACTION, P/N 0250080310. 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

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021