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

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    HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LINK Endo-Model EVO Knee System

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575268542·Proximal tibial spacer, uncemented, Ti6Al4V, fo...

    LINK Endo-Model EVO Knee System

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575185788·Proximal tibial spacer, uncemented, Ti6Al4V, fo...

    LINK Endo-Model EVO Knee System

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575185672·Proximal tibial spacer, uncemented, Ti6Al4V, fo...

    REGIONAL OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CALM CURVE, VERSION 01.00

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PROG VALVE INLINE W SG

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES MANSFIELD·Product code JXG·August 22, 2024

    VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect opiates in urine. One sales unit contains 6 Microtip packs of reagent. Each pack has 50 OP tests.

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·July 9, 2025

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

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

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·June 7, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 24, 2011

    VENATECH CONVERTIBLE

    FDA Adverse Event
    Malfunction ·B.BRAUN MEDICAL SAS·Product code DTK·January 5, 2018

    ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; 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