BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    PHADEBAS RAST ALLERGEN DISCS

    FDA 510(k)
    FDA Class 2 ·Immunology

    LM-Dental 823841

    Device
    EU MDR · Eu Md Class 1 ·LM-Instruments Oy·Not intended for eu market

    KBA3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    AMMONIA ASSAY FOR THE ADVIA 1650

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    STYLE 168 SALINE FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FWM·September 20, 2017

    IMPLANT PDS3000 6PK PILLAR PALATAL EN

    FDA Adverse Event
    Injury ·XOMED MFG JACKSONVILLE·Product code LRK·October 29, 2012

    MERIT CUSTOM KIT

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·February 21, 2014

    HARMONIC SCALPEL GENERATOR

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·December 12, 2007

    dS Breast 7ch 3.0T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

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

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012