BEUDAMED
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    Visby Medical Sexual Health

    FDA 510(k)
    FDA Class 2 ·Microbiology

    KINETRA

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·November 27, 2007

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·February 20, 2024

    ETEST ERTAPENEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT

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

    DEEP BRAIN STIMULATION LEAD

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·November 27, 2007

    UNK

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·March 19, 2008

    BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code QJR·May 22, 2020

    RX ACCULINK CAROTID STENT SYSTEM

    FDA Adverse Event
    Death ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NIM·October 19, 2007

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008

    ECHELON 45 ENDOPATH

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 11, 2011

    TOTAL ASR ACET IMP SIZE 50

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·July 1, 2013

    PULSE GEN MODEL 1000

    FDA Adverse Event
    Injury ·CYBERONICS - HOUSTON·Product code LYJ·October 11, 2024

    BD¿ NEEDLE 1/2 IN. SINGLE USE, STERILE, 30 G

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·October 31, 2022

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021