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

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    KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500

    FDA 510(k)
    FDA Class 2 ·Hematology

    EXHALE DOPPLER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 19, 2025

    FLEXTEND

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·April 8, 2013

    VITALITY

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 6, 2011

    FOUNDATION KNEE SYSTEM

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code HSH·May 7, 2008

    UNKNOWN SUSPENSORY FIXATION DEV

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code GAT·January 10, 2023

    UNKNOWN SUSPENSORY FIXATION DEV

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code GAT·January 9, 2023

    UNKN SUSPENSORY FIXATION DEV

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code MBI·January 12, 2023

    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