BEUDAMED
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    PIONEER SPINOUS PROCESS FUSION PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526189744·LEVAMED ACTIVE ANKLE SUP BLACK L V

    Medline Industries, Inc.

    FDA UDI
    MEDLINE INDUSTRIES, INC.·10198459046278·URETROGRAM SET

    MicroScan

    FDA UDI
    Beckman Coulter, Inc.·15099590655754·MicroScan MH Broth with 3% LHB

    FINOCHIETTO RETRACTOR

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896090712·FINOCHIETTO RETRACTOR SMALL SIZE SPREAD

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383501507·Gutta Percha Points is used to root canal filin...

    APPLE ECG (ELECTROCARDIOGRAPH) APP

    FDA Adverse Event
    Injury ·APPLE INC.·Product code QDA·July 5, 2023

    SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CAPTIA SYPHILIS-G ELISA TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    STELLARIS VISION ENHANCEMENT SYSTEM

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code HQC·February 5, 2026

    AMIA AUTOMATED PD CYCLER SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·December 15, 2020

    AMIA AUTOMATED PD CYCLER SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·January 12, 2023

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 2, 2013

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·September 19, 2014

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·May 25, 2011

    AMIA AUTOMATED PD CYCLER SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·February 15, 2024

    BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Broth with 3% lysed horse blood, Catalog Number 81015 MicroScan Mueller Hinton Broth with 3% Lysed Horse Blood is used for inoculation of MicroScan MICroSTREP plus and MicroFAST panels. MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·May 23, 2018

    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

    Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhythmlink Monopolar Stimulating Probe and 10-1525 Disposable Dilator Set. Product Usage: The Spine Wave Access Kit is comprised of a sterile monopolar stimulating probe (individually packaged by Rhythmlink International) and a set of three sterile disposable dilators (individually packaged by Spine Wave). The Rhythmlink International Monopolar Stimulating Instrument is indicated for stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.

    FDA Recall
    Terminated ·Spine Wave, Inc.·Product code ETN·May 4, 2015

    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