BEUDAMED
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    Genesys Spine Apache® Anchored Cervical Interbody Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SeaSpine

    FDA UDI
    Avalign Technologies, Inc.·00190776149611·POSTERIOR WALL REMOVAL KERRISON, 20mm

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776391430·Posterior Wall Removal Kerrison, 20mm

    NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    POWDER FREE VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES GRENCHEN·Product code HRS·January 30, 2017

    APOLLO GENERATOR

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code GWG·June 11, 2015

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 7, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014

    ONE TOUCH ULTRAMINI METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·May 18, 2009

    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

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 7, 2021