BEUDAMED
    9 results · 30ms · Sources: EU EUDAMED, US FDA

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    Aesculap® SterilContainer(TM) S2 System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528127797·2.4 X 14mm Cannulated Headed Screw, T7

    OPTIFLUX F250NR, MODEL 0500325E

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    ST FRANCIS HSP TULSA OK 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·December 18, 2012

    ILAB ULTRASOUND IMAGING SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - FREMONT (CE)·Product code OBJ·October 17, 2014

    MULTI-LINK VISION CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MAF·June 21, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011

    BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·January 13, 2016