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

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    LOSPA® IS™ Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Navigator 3 Wired Probe Cable

    FDA UDI
    crystal-photonics GmbH·04260152884422·gamma probe system, cable for wired probes

    TMC SpeedMTP

    FDA UDI
    Treace Medical Concepts, Inc.·00810111223652·Inserter Cap

    Olympus

    FDA UDI
    Gyrus ACMI, LLC·00810008184943·ES-IP HD PTZ CAMERA KIT

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694047845·Neuro Utility Drawer, Assembly Kit

    BALANCE MICROPLASTY BROACH

    FDA UDI
    Biomet Orthopedics, LLC·00880304459182·

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694091121·Neuro Utility Drawer Assembly, Top

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694091145·Neuro Utility Drawer Assembly, Side

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694091138·Neuro Utility Drawer Assembly, Drawer

    FLEXIMARC, MODEL CM-0.9-2-10-GG-L

    FDA 510(k)
    FDA Class 2 ·Radiology

    OPTILUX CURING LIGHTS

    FDA 510(k)
    FDA Class 2 ·Dental

    FUSION QUATTRO EXTRACTION BALLOON

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code GCA·December 10, 2024

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 8, 2016

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·October 22, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    SYNCHROMED II

    FDA Adverse Event
    Death ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 1, 2013

    FUSION QUATTRO EXTRACTION BALLOON

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code GCA·June 7, 2024

    SMR CONNECTOR SMALL STD

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code PHX·April 13, 2023

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014