BEUDAMED
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    Innovita Flu A/B Antigen Rapid Test

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776373085·Mini Lambotte Osteotome

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780455974·Integra® Jarit® Mallet, Aluminum Handle, With 2...

    Integra

    FDA UDI
    Provision·B504GS2503980·

    EUM 100Pro

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

    EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MSS - HUMERAL REVERSE LINERS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·February 18, 2026

    WALLFLEX PARTIALLY-COVERED ESOPHAGEAL STENT

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC IRELAND, LTD.·Product code ESW·December 3, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 15, 2011

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIQ·July 26, 2013

    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

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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