BEUDAMED
    13 results · 23ms · Sources: EU EUDAMED, US FDA

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    LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115

    FDA 510(k)
    FDA Class 2 ·Immunology

    RPI SKIN OR AIR TEMPERATURE PROBE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SMARTWIRE/SMARTMAP PRESSURE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·March 27, 2013

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·March 18, 2011

    AED

    FDA Adverse Event
    Malfunction ·WELCH ALLYN PROTOCOL, INC.·Product code MKJ·March 27, 2008

    AIMING ARM/ RADIOLUCENT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code JDS·January 29, 2025

    AIM-ARM RADIOLUC

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code JDS·March 30, 2022

    AIMING ARM/ RADIOLUCENT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code JDS·December 29, 2022

    AIMING ARM/ RADIOLUCENT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·September 19, 2022

    AIMING ARM/ RADIOLUCENT

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code JDS·January 12, 2022

    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 VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024