BEUDAMED
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    EPIVISION SL SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MICROPORT

    FDA UDI
    Microport Orthopedics Inc.·00192629073142·ODYSSEY® KEEL PUNCH HANDLE

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496072102·BE YOU TONIC, SIZE XL, BLU NAVY, GRADUATED COMP...

    STRYKER 2000

    FDA UDI
    Conmed Corporation·10845854004104·STRYKER 2000 SAGITTAL BLADE REPLACEMENT 24.82 X...

    Optimus Drill Q – 4.0mm 55mm

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215109424·

    Genius Total Knee System

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215022228·

    GENTLE COLONICS IRRIGATION SYSTEM

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

    CLEANTEXX POWDERFREE BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVES, BLUE COLOUR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Crescendo Meniscal Insert CR Standard 10mm Size 2

    FDA UDI
    AMPLITUDE SAS·03701089524186·

    LEAD MODEL 304

    FDA Adverse Event
    Malfunction ·LIVANOVA USA, INC.·Product code LYJ·August 10, 2021

    BIPOL LEAD MODEL 300

    FDA Adverse Event
    Malfunction ·LIVANOVA USA, INC.·Product code LYJ·June 3, 2021

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013

    ADVANTAGE SERIES 26

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·April 21, 2011

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008

    LEAD MODEL 304

    FDA Adverse Event
    Malfunction ·LIVANOVA USA, INC.·Product code LYJ·December 7, 2023

    LEAD MODEL 304

    FDA Adverse Event
    Malfunction ·LIVANOVA USA, INC.·Product code LYJ·January 12, 2024

    STRATA®

    FDA Adverse Event
    Malfunction ·MEDTRONIC DOMINICANA·Product code JXG·April 6, 2026

    STRATA®

    FDA Adverse Event
    Injury ·MEDTRONIC DOMINICANA·Product code JXG·April 6, 2026

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; 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

    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