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

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    STROPP (Single Tunnel Repair of Plantar Plate)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Monza Cervical Plate System

    FDA UDI
    Altus Spine, LLC·B41711601181·18mm Cervical Plate, 1 Level

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694004367·LOGIC Distractor, Left Straight

    Ni-Ti - Archwire

    FDA UDI
    ORMCO CORPORATION·00889989029659·ARCH REV.CURVE NITI UP18 DIA. PK10

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694032636·.062 x 6 Double Trocar K-wire

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694068024·.062" x 6" Double Trocar K-wire Sterile Qty 5

    SSP PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STIMTRODE SINGLE USE NERVE STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 8, 2017

    Widex

    FDA UDI
    Widex A/S·05706069897616·WIDEX EVOKE E-FP (Tech Black ) 50, Telecoil, Vo...

    Widex

    FDA UDI
    Widex A/S·05706069895957·WIDEX EVOKE E-FA (Tech Black ) 50, Telecoil, Vo...

    Widex

    FDA UDI
    Widex A/S·05706069923766·WIDEX MOMENT MBB3D 50 (Tech black)

    Widex

    FDA UDI
    Widex A/S·05706069870671·WIDEX EVOKE E-FM (Tech Black ) 50, RC coil

    OT VERIO2 METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 5, 2016

    CAPSUREFIX MRI SURESCAN

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·October 10, 2014

    STEALTSTATION I7 INTEGRATED NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·May 13, 2011

    ACCU-CHEK ® INFORM METER

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·June 10, 2013

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 6 LEFT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 24, 2017

    FLEXI NOZZLE SHORT Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 28, 2016

    FLEXI NOZZLE LONG, 10 Boxes of 25 units each Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 28, 2016