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

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    GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04

    FDA 510(k)
    FDA Class 2 ·Radiology

    DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PELVICFLEXER EXERCISE DEVICE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 20, 2025

    LARGE HEXAGONAL SCREWDRIVER

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HXX·April 8, 2013

    SINGLE-PASS

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008

    CONTAK RENEWAL

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

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    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