BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    FOX EYE ALUMINUM SHIELD, OPHTHALMIC

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    VARIAX

    FDA UDI
    Stryker GmbH·07613327129564·Wrist Fusion Screw Rack T10

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690117339·Modular Knee Stem Pilot 9mm x 150mm

    Reef TH

    FDA UDI
    Seaspine Orthopedics Corporation·10889981203214·Interbody, 9mm x 40mm x 9mm, 15 deg

    Reef TA

    FDA UDI
    Seaspine Orthopedics Corporation·10889981195229·Interbody, 9mm x 40mm x 9mm, 15 deg

    IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    PRIME ZOOM STRETCHER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·February 1, 2013

    ULTRA CART

    FDA Adverse Event
    Malfunction ·JACO·Product code LNX·December 22, 2010

    TIBIAL NAIL, STANDARD T2 TIBIA Ø11X360 MM

    FDA Adverse Event
    Injury ·STRYKER TRAUMA KIEL·Product code HSB·July 17, 2014

    PKG, 5MM INSERT, RETENTION GRASPER, 45CM, P/N 0250080725 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

    Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.

    FDA Enforcement
    Class II ·Terminated·Capintec Inc·April 1, 2020