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

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    ANTI-MUSCLE ACTIN PRIMARY ANTIBODY

    FDA 510(k)
    FDA Class 2 ·Immunology

    CERCON CERAM EXPRESS CERAMIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ULTRASKIN HYDROPHILIC GUIDE WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VASO VIEW HEMOPRO

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·March 5, 2014

    ARCHITECT I2000 ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JJE·December 30, 2010

    LINOX S 65

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code LWS·December 21, 2012

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    HEMOCHRON SIGNATURE ELITE

    FDA Adverse Event
    Malfunction ·ACCRIVA DIAGNOSTICS·Product code JPA·May 25, 2016

    PENTAX

    FDA Adverse Event
    Injury ·PENTAX·Product code EOQ·January 10, 2017

    PKG, BABCOCK FORCEPS, P/N 0250080241. 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