BEUDAMED
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    MPowRx Snoring Solution (also known as Good Morning Snore Solution)

    FDA 510(k)
    FDA Class 2 ·Dental

    Control Syringe

    FDA UDI
    ARGON MEDICAL DEVICES, INC.·00886333207312·12cc Soft Touch Control Syringe FG/PP/RA w/Rese...

    IRRIGATION SYSTEM

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

    FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD BACTEC¿ MGIT¿ 960 PZA KIT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MJA·May 8, 2025

    DEXTRUS 4135

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVN·June 27, 2013

    STELLARIS OPTIMIZED STABILITY VACUUM PACK

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB·Product code HQC·July 13, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 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