BEUDAMED
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    BEE HA

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180157941·5 MM DIA., 33 CM, NEEDLE HOLDER STRAIGHT TUNGST...

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776209025·Lap Needle Hldr Str TC Tip SA

    Restore

    FDA UDI
    KEYSTONE DENTAL, INC.·D768L25056002K0·Oring Abutment

    Restore

    FDA UDI
    KEYSTONE DENTAL, INC.·D768L25056004K0·Oring Abutment

    Restore

    FDA UDI
    KEYSTONE DENTAL, INC.·D768L25056003K0·Quick Abutment

    EUROCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    InBody

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRISMAFLEX ST150

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDI·December 13, 2019

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·November 14, 2014

    COULTER® AC-T DIFF 2¿ ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code GKZ·September 16, 2011

    GYNECARE TVT RETROPUBIC SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 26, 2013

    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

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013