BEUDAMED
    9 results · 22ms · Sources: EU EUDAMED, US FDA

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    FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STERLING

    FDA UDI
    BENCO DENTAL SUPPLY CO.·00366975065278·

    EXCERA FITRITE TOTAL HIP ARTHROPLASTY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE

    FDA 510(k)
    FDA Class 2 ·Dental

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·April 18, 2014

    APOGEE SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code OTP·January 30, 2013

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·December 9, 2010

    EVOLUT FX DCS

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NPT·November 10, 2025

    PKG, 3MM INSERT, MARYLAND, FORCEPS CURVED, 20CM, P/N 0250282011 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