BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    FUJI HG-M INTENSIFYING SCREEN

    FDA 510(k)
    FDA Class 1 ·Radiology

    SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Guided DAS Surgical Kit

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PROQPAQ MD DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code LDD·January 8, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·January 2, 2011

    12/14 ARTICUL 40MM M SPEC+5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·July 18, 2014

    5.0MM TI SIDE-OPENING SCREW 40MM

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code MNI·June 5, 2012

    5.0MM TI SIDE-OPENING SCREW 40MM

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code MNI·June 5, 2012

    TI NUT 11MM WIDTH ACROSS FLATS

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code MNI·June 5, 2012

    TI NUT 11MM WIDTH ACROSS FLATS

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code MNI·June 5, 2012

    ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer. Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 30, 2015

    PKG, DOLPHIN FORCEPS, SERRATED SPOON, P/N 0250080280. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014