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

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    Imbibe Aspirating XIA Taps

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

    DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    AYCAN WORKSTATION OSIRIX PRO

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 6, 2025

    COREVALVE TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·November 18, 2017

    FUJIFILM BALLOON BS-4

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

    ADVIA CENTAUR XP TSH3-ULTRA (TSH3-UL) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code JLW·June 3, 2013

    LDR SPINE ROI-C INTERBODY FUSION DEVICE

    FDA Adverse Event
    Injury ·LDR MEDICAL·Product code OVE·September 5, 2014

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·June 2, 2011

    PKG, NEEDLE NOSE FORCEPS, P/N 0250080288. 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