BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    BAYER SPECIAL CHEMISTRY CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033380·Baltic Denture System BDLoad BDLoad Mw6 PLSEbi...

    IMPLANTABLE ADAPTOR 033-380

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BIOTEQUE VAGINAL DILATOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    FR CLERMONT FERRAND

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·October 3, 2012

    MERCY HSP PITTSBURGH PA 1

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DWE·May 7, 2009

    HCSG/HENDRICK MED/ABLNE TX 1

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA, INC.·Product code DWE·February 16, 2010

    DIDECO COMPACTFLO EVO

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·January 16, 2013

    DIDECO COMPACTFLO EVO

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code KFM·December 13, 2012

    DIDECO COMPACTFLO EVO

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·October 18, 2012

    ACCENT SR

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·April 3, 2013

    ADVANTAGE SERIES 29

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·March 22, 2011

    BD SYRINGE

    FDA Adverse Event
    Injury ·BD MEDICAL SYSTEMS - INDUSTRIAL SITE·Product code KYZ·April 15, 2008

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    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

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016