BEUDAMED
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    MYLABONE ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Biologic

    FDA UDI
    NATUS MEDICAL INCORPORATED·00382830052160·Square Square Snap Electrodes - aggressive adhe...

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00860006434571·Tasso+ convenience kit allows self-collection o...

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383554206·Gutta Percha Points is used to root canal filin...

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93071016054TC0·Toothed Curette #5 LEFT 16" 6" handle

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93071016053TC0·Toothed Curette #5 RIGHT 16" 6" handle

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93071016050TC0·Toothed Curette #5 STR 16" 6" handle

    Swoop Transmit and Receive Radio Frequency Head Coil

    FDA UDI
    Hyperfine Operations, Inc.·00860000606165·Transmit and Receive Radio Frequency (RF) Head ...

    The Orthodontic Store

    FDA UDI
    Young Innovations, Inc.·00843471157756·T D-Form 016

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383501781·Gutta Percha Points is used to root canal filin...

    Procure

    FDA UDI
    Twin Med, LLC·10840330700716·Trach Tie Large, Foam w/moisture repellent back...

    EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MIS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Young Specialties

    FDA UDI
    Young Innovations, Inc.·00840326426111·NiTi Thermal Archwire, D-Form .016 10EA

    KAMRA

    FDA Adverse Event
    Injury ·ACUFOCUS, INC.·Product code LQE·October 15, 2015

    Ascendant

    FDA UDI
    Choice Spine, LP·10885862260543·

    PAINSMART IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·April 30, 2013

    CRYSTALENS INTRAOCULAR LENS

    FDA Adverse Event
    Injury ·BAUSCH + LOMB SURGICAL·Product code NAA·August 27, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 11, 2011

    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    FDA Enforcement
    Class II ·Terminated·Optovue Inc.·October 31, 2012