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

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    JOBST READY-TO-WEAR GAUNTLET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MAGNIVISION

    FDA UDI
    FGX INTERNATIONAL INC.·00193033518915·

    MAGNIVISION

    FDA UDI
    FGX INTERNATIONAL INC.·00193033518908·

    MAGNIVISION

    FDA UDI
    FGX INTERNATIONAL INC.·00193033518878·

    MAGNIVISION

    FDA UDI
    FGX INTERNATIONAL INC.·00193033518922·

    MAGNIVISION

    FDA UDI
    FGX INTERNATIONAL INC.·00193033518861·

    MAGNIVISION

    FDA UDI
    FGX INTERNATIONAL INC.·00193033518892·

    MAGNIVISION

    FDA UDI
    FGX INTERNATIONAL INC.·00193033518885·

    DIMENSION HAIC ASSAY, MODEL DF105

    FDA 510(k)
    FDA Class 2 ·Hematology

    OSMED TISSUE EXPANDER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 20, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·March 10, 2011

    PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS REDWOOD CITY·Product code MGB·March 14, 2008

    BD SAFETYGLIDE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·October 19, 2023

    ARROW AGBA PICC NAVICURVE: 3L 6FR X 55CM BP

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL LLC·Product code LJS·April 23, 2025

    ARROW PI PICC NAVICURVE: 1L 4FR X 55CM W BP

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL LLC·Product code LJS·August 5, 2025

    ARROW AGBA PICC NAVICURVE: 2L 5.5FR X 55CM TCG

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL LLC·Product code LJS·January 16, 2025

    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