BEUDAMED
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    SABOURAUD DEXTROSE AGAR

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ID NOW COVID-19 2.0 TEST KIT 24T (EUA)

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 14, 2024

    ID NOW COVID-19 2.0 TEST KIT 24T (EUA)

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QWR·June 28, 2024

    ID NOW COVID-19 2.0 TEST KIT 24T (EUA)

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QWR·June 28, 2024

    ID NOW COVID-19 2.0 TEST KIT 24T (EUA)

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QWR·June 28, 2024

    NEUROBLATE SYSTEM

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

    SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN

    FDA 510(k)
    FDA Class 2 ·Radiology

    AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS (MN)·Product code OTP·May 20, 2014

    SCREW

    FDA Adverse Event
    Injury ·Product code HWC·October 17, 2012

    NONE

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DTB·August 31, 2010

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017