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

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    OPHTHALMIC FORCEPS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    VITROS

    FDA UDI
    ORTHO CLINICAL DIAGNOSTICS·10758750000715·VITROS Immunodiagnostic Products Total T3 Range...

    Helix

    FDA UDI
    Nuvasive, Inc.·00887517136084·Helix R Plate, 68mm 3-Level

    ACUMED

    FDA UDI
    Acumed LLC·10806378041600·Polarus® Height Gauge Base Assembly

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306835469·Basket Cannula, 4mm x 30cm, Blue Aluminum Handle

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197491471·Titanium Blade 51x178...

    EYECAP IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BIODESIGN 4-LAYER TISSUE GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH, INC.·Product code FTM·April 3, 2014

    INTELLIVUE MX800 PATIENT MONITOR

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code MHX·October 11, 2012

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 28, 2007

    Heat Activated Niti Arches, Natural, Upper, .019x 25", Arch Wires. Packaged in 19 packages of 100 and 6 packages of 10. Highland Metals, Inc. Wire used for orthodontic treatment to place in the brackets to shape teeth.

    FDA Recall
    Terminated ·Highland Metals·Product code D·July 12, 2011

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018