BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

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    8ch Foot Ankle Coil

    FDA 510(k)
    FDA Class 2 ·Radiology

    Masel

    FDA UDI
    Ortho Organizers, Inc.·00190707041076·Choice™ Angled Bracket Removing Pliers

    ProLift

    FDA UDI
    Life Spine, Inc.·00190837106188·Static Expandable Cage Trial, 10mm x 28mm x 15m...

    MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS

    FDA 510(k)
    FDA Class 2 ·Radiology

    PENUMBRA SYSTEM MAX ASPIRATION TUBING

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·June 24, 2015

    ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Injury ·HEARTWARE, INC·Product code DSQ·October 8, 2014

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code LWP·June 7, 2013

    HIRES 90K

    FDA Adverse Event
    Injury ·ADVANCED BIONICS LLC·Product code MCM·June 30, 2011

    Precise Digital Accelerator Delivery of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 26, 2012

    Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 20, 2013

    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