BEUDAMED
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    POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517565235·CoRoent Ant TLIF PEEK, 13x11x34mm 4°

    ArgenIS

    FDA UDI
    ARGEN CORPORATION, THE·D818131344·TiBase SEV 3.6 1.0G E

    Plateau C

    FDA UDI
    Life Spine, Inc.·00190837093594·

    G+ SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    XXL? VASCULAR

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code KNQ·October 1, 2014

    PELVICOL 2CM X 7CM 1.0MM

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TISSUE SCIENCE·Product code FTL·May 17, 2013

    CAPSUREFIX NOVUS MRI

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code NVN·June 16, 2011

    ELECSYS TSH ASSAY

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JLW·November 9, 2020

    cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·February 26, 2014

    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

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020