BEUDAMED
    14 results · 18ms · Sources: EU EUDAMED, US FDA

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    URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    E-Z READERS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033521205·

    E-Z READERS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033521335·

    Cosmolock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0130190·T-Handle, Head Persuader, 5.5mm

    E-Z READERS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033521311·

    E-Z READERS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033521328·

    HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    3CC NMT SAFETY SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MONGOOSE ANGIOGRAPHIC CATHETER

    FDA Adverse Event
    Injury ·TOGO MEDIKIT CO.LTD.·Product code DQO·December 15, 2017

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    UNKNOWN·Product code ILS·March 20, 2013

    MERIT CUSTOM KIT

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·February 4, 2011

    CUSTOM PAK

    FDA Adverse Event
    Injury ·ALCON - HOUSTON·Product code LRO·March 14, 2008

    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

    HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·March 27, 2024