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    RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    PFT Kit B, 31MM O.D.

    FDA UDI
    A-M SYSTEMS, LLC·00817081022056·Pulmonary Function Testing Kit B, 31MM O.D.

    Ophthalmic Retractor

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100967·DESMARRES LID RETRACTOR #1

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515026735·Doyen Retr, 2 1/8"x 3", 8 1/2"

    COMPUTED TOMOGRAPHY X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00

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

    GYNECARE TVT OBTURATOR

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·November 4, 2019

    PINNACLE MTL INS NEUT44IDX62OD

    FDA Adverse Event
    Injury ·8010379 DEPUY INTL., LTD.·Product code KWA·June 21, 2013

    5.0CM SHORT ATTACHMENT

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 17, 2014

    LIFEPAK CR PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·June 23, 2011

    AVALON FM30 FETAL MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code HGM·September 27, 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