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

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    BONART ART-L3 LED CURING LIGHT

    FDA 510(k)
    FDA Class 2 ·Dental

    INQWIRE DIAGNOSTIC GUIDE WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID)

    FDA 510(k)
    FDA Class 2 ·Radiology

    PEN NEEDLE 31GX5MM 7 PACK

    FDA Adverse Event
    Malfunction ·EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA·Product code FMI·June 7, 2024

    PEN NEEDLE 31GX5MM 7 PACK

    FDA Adverse Event
    Malfunction ·EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA·Product code FMI·June 6, 2024

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code MMI·April 16, 2013

    ANGIOMAT ILLUMENA

    FDA Adverse Event
    Malfunction ·LIEBEL-FLARSHEIM CO.·Product code DXT·June 17, 2008

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER-SILICON VALLEY·Product code GEX·April 12, 2011

    EVOLUT FX DCS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 1, 2025

    Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 14, 2017

    BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, and PAK6455 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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    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