BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    LTD POLYAXIAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LEKON

    FDA UDI
    C A I INDUSTRIES CORP·00807689004011·Acupuncture needles

    PRONOVA NONABSORBABLE SUTURE, USP

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STANDARD BINDER LIFT 2.0

    FDA Adverse Event
    Malfunction ·BINDER LIFT INC., DBA PHASE·Product code IKX·September 18, 2025

    DEBAKEY FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·April 8, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·March 10, 2011

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    CHLORAPREP ONE STEP HI-LITE ORANGE

    FDA Adverse Event
    Malfunction ·CAREFUSION 213, LLC 0113·Product code KXG·May 31, 2021

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code HRS·March 14, 2014

    PKG, 5MM INSERT, ATRAUMATIC GRASPER FORCEPS, DOUBLE ACTION 45CM, P/N 0250080585 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