BEUDAMED
    18 results · 24ms · Sources: EU EUDAMED, US FDA

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    B4C System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Disposable Blade

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113196·BARD-PARKER BLADE #11 PACK OF 50

    Disposable Blade

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113202·BARD-PARKER BLADE #15 PACK OF 50

    COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3

    FDA 510(k)
    FDA Unclassified ·Unknown

    HYDROFLEX PENILE PROSTHESIS

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FHW·November 25, 1996

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 29, 2025

    MESHGRAFT II COMPLETE

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL·Product code FZW·May 8, 2013

    ARCHITECT CA 19-9XR

    FDA Adverse Event
    Malfunction ·ABBOTT GERMANY·Product code NIG·September 26, 2019

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 17, 2014

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMELRY NELLCO·Product code CBK·June 27, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·August 11, 2011

    MESHGRAFT II COMPLETE

    FDA Adverse Event
    Injury ·ZIMMERBIOMET SURGICAL·Product code FZW·August 18, 2015

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·May 30, 2018

    PDSII CLR 27IN 3-0 S/A FS-1

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code NEW·October 31, 2019

    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

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021