BEUDAMED
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    ARTHREX UNIVERS II CA HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776163402·Farrior Spec Oval Oblique . Ebonized

    EVONOS

    FDA UDI
    Gyrus ACMI, LLC·00821925014411·EAR SURGERY SPECULUM ROUND 7.5MM

    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

    Biogel

    FDA UDI
    Bosma Enterprises·10818634023534·Biogel Sensor Surgical 7.5 - 50 Pair/Box

    EASYRA UREA NITROGEN AND CREATININE REAGENTS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CHIENMAX VIETNAM CO. LTD POWDER FREE BLUE NITRILE EXAMINATION GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    RESTORE ADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 22, 2014

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FPA·May 24, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 30, 2014

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    FDA Adverse Event
    Injury ·STAAR SURGICAL CO.·Product code HQL·June 14, 2011

    VITEK® REVEAL¿ SENSOR PANEL

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·June 23, 2025

    VITEK® REVEAL¿ SENSOR PANEL

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·June 24, 2025

    VITEK® REVEAL¿ SENSOR PANEL

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·June 23, 2025

    VITEK® REVEAL¿ SENSOR PANEL

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·June 24, 2025

    VITEK® REVEAL¿ SENSOR PANEL

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·June 24, 2025

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019