BEUDAMED
    16 results · 22ms · Sources: EU EUDAMED, US FDA

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    InMode RF System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100226·THORLAKSON ASPIRATING SPECULUM

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100240·SILICONE TUBING FOR ASPIRATING SPECULUM

    MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY

    FDA 510(k)
    FDA Unclassified ·Unknown

    ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING (CONTAINING GLYCERINE)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    NEEDLE NS 30GA 7/8IN BSG W/O SIL W/O SHD

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·April 15, 2025

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014

    ATTAIN ABILITY

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·June 7, 2013

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 15, 2015

    D902 LILLIPUT ECMO M PHISIO

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·April 7, 2022

    LILLIPUP PMP, LILLIPUT PMP INTEGRATED

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·June 27, 2022

    ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    Precise Treatment Table. To be used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 17, 2013

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 2014

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

    FDA Enforcement
    Class II ·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019