BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC

    FDA 510(k)
    FDA Class 2 ·Radiology

    Biomet Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304554481·

    UMBILI-CATH

    FDA Adverse Event
    Malfunction ·UTAH MEDICAL PRODUCTS·Product code FOS·August 20, 2015

    VITEK 2 YEAST CASPOFUNGIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SONOSURG ULTRASONIC SURGICAL SYSTEM

    FDA 510(k)
    FDA Unclassified ·Unknown

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014

    CORE IMPACTION DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·June 3, 2013

    STERLING BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·June 27, 2011

    ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·December 10, 2020

    33CM DORSEY GRASPER FORCEPS, P/N 0250080319. 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