BEUDAMED
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    VANGUARD REPROCESSED PULSE OXIMETER SENSORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Bard® Dimension® Stone Basket

    FDA UDI
    C. R. Bard, Inc.·00801741066825·Bard® Dimension® Stone Basket

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809871821·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND OPEN T...

    Entuit Thrive LP

    FDA UDI
    XERIDIEM MEDICAL DEVICES, INC.·00827002356542·

    PERMACEM / PERMACEM DUAL

    FDA 510(k)
    FDA Class 2 ·Dental

    PHOENIX DIGITAL EEG

    FDA 510(k)
    FDA Class 2 ·Neurology

    WATCHPAT100

    FDA Adverse Event
    Injury ·ITAMAR MEDICAL LTD.·Product code MNR·November 12, 2007

    DEVICE 8252410 NIM-NEURO 2.0 INTERFACE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code IKN·February 21, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 4, 2013

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 15, 2011

    ACUITY STEERABLE

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008

    STERRAD® NX STERILIZER

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·February 20, 2018

    Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA 510 K042396 Used in several T2 systems intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide Wires: T2 Tibial Nailing Systems, T2 Femoral Nailing Systems, T2 Ankle Nailing Systems, and T2 Humerus Nailing Systems

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·February 5, 2014

    Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA 510 K042396 Used in several T2 systems intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide Wires: T2 Tibial Nailing Systems, T2 Femoral Nailing Systems, T2 Ankle Nailing Systems, and T2 Humerus Nailing Systems

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HSB·November 7, 2013

    Vasoshield Syringe Packs, Model VH-5001

    FDA Recall
    Open, Classified ·Maquet Cardiovascular, LLC·Product code GBX·December 22, 2022

    Hemopro 2 with Vasoshield, Model VH-4001

    FDA Recall
    Open, Classified ·Maquet Cardiovascular, LLC·Product code GEI·December 22, 2022

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018