BEUDAMED
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    CD HORIZON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CD HORIZON BALLAST SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NKB·December 9, 2019

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517577443·CoRoent Ant TLIF PEEK, 13x12x32mm 8°

    Oticon

    FDA UDI
    Oticon A/S·05707131258434·H16, MINIRITE 312 WL STG

    Ophthalmic Spatula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668102428·NAGAHARA PHACO CHOPPER SHORT HANDLE

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613024307·Cottle Dorsal Scissors, TC, Angled Rounded Shan...

    Aileron Expandable Posterior Fusion System

    FDA UDI
    Life Spine, Inc.·00190837000080·

    Aileron Expandable Posterior Fusion System

    FDA UDI
    Life Spine, Inc.·00190837000073·

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613070434·Cottle-Dorsal Scissors,TC, Straight, Blunt, Ang...

    BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA

    FDA 510(k)
    FDA Class 2 ·General Hospital

    POWDER FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK

    FDA 510(k)
    FDA Class 1 ·General Hospital

    INOGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 1, 2014

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·May 29, 2013

    SYSTEM 6 CHARGER

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·June 11, 2011

    Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·February 26, 2014

    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

    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