BEUDAMED
    9 results · 25ms · Sources: EU EUDAMED, US FDA

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    SIGMA 5000 SERIES, IMAGIC

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYNERGY 4.0 MM, 4.5 MM VLS SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENSITE 3000 SYSTEM, MODEL EE3000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 13, 2025

    UNKNOWN EXTERNAL NEUROSTIMULATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LGW·April 16, 2013

    DISCYPHOR CATHETER SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SPINE LLC·Product code BSP·June 17, 2008

    SYNCHROMED

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROLOGY·Product code LKK·April 7, 2011

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015