BEUDAMED
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    INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000

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

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450508503·

    POWER SUPPLY / BATTERY CHARGER

    FDA Adverse Event
    Malfunction ·ELPAC·Product code IYN·March 28, 2011

    POWER SUPPLY/BATTERY CHARGER

    FDA Adverse Event
    Malfunction ·ELPAC·Product code ITX·July 30, 2010

    POWER SUPPLY/BATTERY CHARGER

    FDA Adverse Event
    Malfunction ·ELPAC·Product code ITX·June 25, 2010

    CLARIS PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5; VACUFLOW+ WITH HOLDER BLOOD COLLECTION SET, MODEL 82021/3/5 WITH HOLDER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RINGLOC RIMCUP SHELL

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code LPH·August 31, 2017

    18MM 30CM HEMASHIELD PLAT WDV

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code MAL·April 8, 2013

    TENDRIL SDX

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·May 27, 2008

    RESERVOIR 3CC

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·April 4, 2011

    MIH MOD CUP INSERTER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LXH·August 17, 2017

    ECHELON

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·September 25, 2024

    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