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

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    ORTHOMESH

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0131150·Rocker, Hinged Locking

    ACE VERSANAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACTIS ADJUSTABLE CONSTRICTION LOOP

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

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 28, 2024

    MUSTANG¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LIT·April 23, 2013

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·March 17, 2011

    RIATA PASSIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

    BD ULTRA FINE¿ PEN NEEDLES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·April 27, 2020

    Cocoon Convective Warming System, Product Code: CWS4000 (110V).

    FDA Enforcement
    Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024