BEUDAMED
    13 results · 32ms · Sources: EU EUDAMED, US FDA

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    U04

    FDA 510(k)
    FDA Class 2 ·Radiology

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890109420·Zirlux Multi-Unit Abutment 1 mmH compatible wit...

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0100420·Assembly, Caddie, Adjustable Cross Links

    SL-PLUS AND SLR-PLUS STEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RADIESSE DERMAL FILLER

    FDA Adverse Event
    Injury ·BIOFORM MEDICAL, INC.·Product code LMH·January 26, 2009

    MEDTRONIC EXTENDED

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 30, 2025

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code MGB·May 2, 2023

    VENFLON

    FDA Adverse Event
    Injury ·BECTON DICKINSON·Product code FOZ·March 15, 2013

    ETERNITY X-70

    FDA Adverse Event
    Injury ·B+L FOR ADVANCED VISION SYSTEMS·Product code HQL·March 4, 2011

    TENDRIL SDX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 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