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

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    VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    VIASPAN

    FDA Adverse Event
    Other ·FRESENIUS KABI AUSTRIA GMBH·Product code KDL·March 26, 2012

    InVision Precision Cardiac Amyloid

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEMODIALYSATE SOLUTIONS

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

    STERRAD 100NX STERILIZER

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·February 5, 2013

    ATLAS II PLUS HF CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·July 18, 2014

    NC QUANTUM APEX PTCA DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·January 3, 2011

    PKG, 5MM INSERT, RIGHT ANGLE FORCEP, 45CM P/N 0250080729 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