BEUDAMED
    13 results · 36ms · Sources: EU EUDAMED, US FDA

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    PODIATRIC MATERIAL

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    XLIF

    FDA UDI
    Nuvasive, Inc.·00887517452740·XLIF Kerrison, 2mm

    FIXOS

    FDA UDI
    Stryker GmbH·07613252708742·Drawer Screw-Racks

    Reef TH

    FDA UDI
    Seaspine Orthopedics Corporation·10889981203368·Interbody, 9mm x 40mm x 13mm, 20 deg

    Reef TA

    FDA UDI
    Seaspine Orthopedics Corporation·10889981195373·Interbody, 9mm x 40mm x 13mm, 20 deg

    Trinias

    FDA UDI
    SHIMADZU CORPORATION·04540217048922·

    BIODENTINE

    FDA 510(k)
    FDA Class 2 ·Dental

    EmoLED (v. 2-USA)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 2, 2013

    INFINITI VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·December 22, 2010

    V.A.C. THERAPY

    FDA Adverse Event
    Injury ·KCI USA INC.·Product code OMP·June 19, 2014

    PKG, 5MM X 45CM, INSERT, KELLY FORCEPS, P/N 0250080753 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