BEUDAMED
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    IV PREP KIT (NON-STERILE)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DePuy Songer Spinal Cable System

    FDA UDI
    Pioneer Surgical Technology, Inc.·10846468005259·Bar, Flat, Ti 2-Pack, NS, AcroMed

    Solstice Occipito-Cervico-Thoracic System

    FDA UDI
    Life Spine, Inc.·00190837015169·

    Instrument Case

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110928·STERILIZING CASE SINGLE VR

    Songer® Spinal Cable System

    FDA UDI
    Pioneer Surgical Technology, Inc.·00840298704408·(2) Bar, Flat

    LAB-SITE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IMPROVED DENTAL OPERATING LIGHT

    FDA 510(k)
    FDA Class 1 ·Dental

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 18, 2014

    NK II SINTERLOCK FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code HSA·January 17, 2013

    REVEAL DX

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code DSI·December 14, 2010

    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 GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

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