BEUDAMED
    16 results · 31ms · Sources: EU EUDAMED, US FDA

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    SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    XENMATRIX

    FDA UDI
    Davol Inc.·00801741129049·XenMatrix AB Surgical Graft, 30 cm x 45 cm

    SSW CARBIDE TRIMMING AND FINISHING

    FDA UDI
    Ss White Burs, Inc.·D6901530452·12 BLADE FINISHING CARBIDE 7304 - 5 PACK

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100134·KRATZ-BARRAQUER SPECULUM LEFT EYE

    BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·September 26, 2022

    Truliant

    FDA UDI
    Exactech, Inc.·10885862523440·PS NOTCH CUTTER, SIZE 4.5

    MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020

    FDA 510(k)
    FDA Class 2 ·Neurology

    BIOHARNESS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·June 8, 2013

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DRY·June 17, 2011

    MBT CEM KEEL TIB TRAY SZ4

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code NJL·September 5, 2008

    BD LUER-LOK¿ SYRINGE PHARMACY CONVENIENCE TRAY

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·May 18, 2023

    iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    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

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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