BEUDAMED
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    VORTEX CANNULA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489112846·TrueForm Nitrile Exam Gloves, Large

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065722·INTRAORAL ELASTICS 4,5 oz 3/8" orange

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065753·INTRAORAL ELASTICS 6,5 oz 5/16" blue

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450384794·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450255704·

    PROLITE PULSED LIGHT SYSTEM

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

    OB-1 FETAL MONITOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    1049092-2018-00287

    FDA Adverse Event
    Injury ·Product code FRO·May 15, 2018

    9618003-2021-01239

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·July 15, 2021

    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

    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 Recall
    Terminated ·Optovue Inc.·Product code OBO·September 7, 2012

    V SERIES MONITOR

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 16, 2014

    UNKNOWN PREFILL

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code NZW·April 20, 2011

    Dressing, wound, drug

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·September 9, 2021

    MESH ¿ VENTRALEX

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·April 10, 2023

    9618003-2021-01006

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·May 28, 2021

    9618003-2021-01210

    FDA Adverse Event
    Injury ·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·July 15, 2021

    Dressing, wound, drug

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·October 17, 2022