BEUDAMED
    12 results · 26ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION OF PASCO MIC AND MIC/ID PANELS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Armada

    FDA UDI
    Nuvasive, Inc.·00887517464293·Armada Ti Spoon Retractor, 20mm

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198727·AK3 Ultra Insert Trial Size 4, 20mm

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867401068·2.4mm Snap-off FT Pin 20mm

    KRD1 PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Crownjun Nylon Suture

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

    AT HOME DRUG TEST PHARATECH

    FDA Adverse Event
    PHAMATECH·Product code MVO·September 24, 2003

    UNKNOWN DEPUY FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWY·March 7, 2013

    ATTAIN SELECT II

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DQY·February 15, 2011

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MPRI·Product code NVY·August 8, 2014

    PECTUS SYSTEM JANTON 12" TI PECTUS BAR 3.048CM (12") (L) TITANIUM

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·January 2, 2019

    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013