BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    AFINION ACR AND ACR CONTROL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496072409·BE YOU STEP-UP, SIZE ML, BLU TONIC, OPAQUE MICR...

    MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    OMNIGUIDE BEAMPATH FIBER AND ADAPTER

    FDA Adverse Event
    OMNIGUIDE, INC.·Product code GEX·October 19, 2010

    UNKNOWN IMPLANTABLE PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·April 23, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 8, 2011

    *

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008

    CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015