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

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    ADVIA IMS

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00143441·

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040071403·Surgical Bur FG 2

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001344·artVeneer life upper anteriors, IL, C2

    24PW - Hanta Virus

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588013442·Hanta Virus - 24 Poly White

    TUFF UNICON IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·March 5, 2025

    TUFF UNICON IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·March 5, 2025

    ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 3, 2025

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR INC.·Product code MGB·October 12, 2010

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NTE·October 12, 2010

    EEA 21MM SINGLE USE STAPLER WITH 3.5MM

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY USSC·Product code GDW·March 6, 2013

    ULTRAFLEX

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code ESW·February 25, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC·Product code JAA·February 22, 2008

    T:slim Insulin Delivery System Insulin Infusion Pump

    FDA Enforcement
    Class I ·Terminated·Tandem Diabetes Care Inc·February 19, 2014

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 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