BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

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    VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    EMIT 2000 GENTAMICIN PLUS ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 7 HOLES/81MM

    FDA Adverse Event
    Injury ·WRIGHTS LANE: SYNTHES USA PRODUCTS LLC·Product code HRS·December 14, 2017

    ARTEGRAFT COLLAGEN VASCULAR GRAFT

    FDA Adverse Event
    Malfunction ·ARTEGRAFT, INC.·Product code LXA·January 25, 2007

    AKREOS ADAPT AO MICRO INCISION LENS

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code HQL·March 25, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 8, 2008

    HUIBREGTSE NEEDLE KNIFE PAPILLOTOME

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code KNS·July 19, 2022

    Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013