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

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    LIPOPRINT SYSTEM, LDL SUBFRACTIONS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GC Initial™

    FDA UDI
    Gc America Inc.·14548161315074·GC Initial™ LiSi Press Ingot LT-B (3gx5)

    GC Initial™

    FDA UDI
    Gc America Inc.·D0470103371·GC Initial™ LiSi Press Ingot LT-B (3gx5)

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890103370·Zirlux Multi-Unit Abutment 1.5 mmH compatible w...

    Polystar Selection EDITION / Polystar Selection EDITION HD

    FDA UDI
    Merz Dental GmbH·D7091010337·Living mould chart Polystar Selection EDITION /...

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036007584·

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345024021·Paddle Shaver, 7mm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0103070·Shaver, Closed, 7mm

    DANIELS SHARPSMART REUSABLE SHARPS CONTAINER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MTP DISPOSABLE TROCAR VALVES

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

    APTIMA SARS-COV-2 ASSAY

    FDA Adverse Event
    Malfunction ·HOLOGIC INCORPORATED·Product code QJR·February 18, 2022

    PROMUS ELEMENT¿ PLUS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·March 19, 2013

    OLYMPUS EVIS EXERA II BRONCHOVIDEOSCOPE

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEM CORPORATION·Product code EOQ·February 11, 2011

    AXSYM DIGOXIN III

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code KXT·May 11, 2007

    APTIMA SARS-COV-2 ASSAY

    FDA Adverse Event
    Malfunction ·HOLOGIC INCORPORATED·Product code QJR·June 23, 2022

    SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363

    FDA Enforcement
    Class II ·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. 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