BEUDAMED
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    Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017910·K-Wire, Double Ended, Trocar Point, Diameter Si...

    Oticon

    FDA UDI
    Oticon A/S·05707131338907·SIYA 1, BTE 13 PP 2.4G 105 C091

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017927·K-Wire, Double Ended, Trocar Point, Diameter 0....

    UV-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LENS

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL CO.·Product code HQL·November 17, 2004

    GYNECARE TVT EXACT CONTINENCE SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 21, 2025

    ALARIS INFUSION PUMP

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH·Product code FRN·October 7, 2008

    PK DISSECTING FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 26, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

    BACT/ALERT MP - 419744

    FDA Adverse Event
    Malfunction ·BIOMERIEUX INC.·Product code MDB·December 5, 2019

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Malfunction ·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQY·May 5, 2023

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Death ·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQY·April 25, 2023

    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,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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