BEUDAMED
    19 results · 26ms · Sources: EU EUDAMED, US FDA

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    ULTIMA METAL-ON-METAL ACETABULAR CUP

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    Beaver®

    FDA UDI
    Beaver-Visitec International, Inc.·30886158020050·MICRO KNIFE, 45 DEGREE, 10/BX

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964014152·The ENDO CARRY-ON Procedure Kit contains all of...

    Straumann

    FDA UDI
    Preat Corporation·00842092129432·Straumann® BL NC-compatible Healing Abutment - ...

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001523·artVeneer life lower anteriors, UBIM, D4

    TiMesh

    FDA UDI
    MEDTRONIC PS MEDICAL, INC.·00643169620735·FLEXMESH 8001523-6 1.5 MEDIUM RIGID

    TiMesh®

    FDA UDI
    MEDTRONIC PS MEDICAL, INC.·00721902858765·FLEXMESH 8001523-6 1.5 MEDIUM RIGID

    KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    FREEDOM, MODEL 4660

    FDA 510(k)
    FDA Unclassified ·Unknown

    VERTEBRAL BODY STENT-MEDIUM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code NDN·December 15, 2022

    TUFF UNICON IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·April 26, 2026

    SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·June 2, 2017

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 5, 2013

    CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code KRH·February 25, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·February 20, 2008

    Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.

    FDA Enforcement
    Class II ·Terminated·Sunrise Medical (US) LLC·December 11, 2013

    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

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024