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

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    Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T

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

    FUJIFILM BALLOON BS-4

    FDA Adverse Event
    Injury ·FUJIFILM CORPORATION·Product code FDA·January 14, 2021

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 11, 2014

    LIBERTY CYCLER SET, SINGLE PATIENT CONN

    FDA Adverse Event
    Malfunction ·REYNOSA MANUFACTURING·Product code FKX·August 19, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·July 23, 2013

    PKG, 5MM INSERT, HOOK SCISSORS, 45CM, P/N 0250080573 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