BEUDAMED
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    REST ASSURED EXTRA COMFORT NITE PROTECTOR

    FDA 510(k)
    FDA Unclassified ·Unknown

    Oticon

    FDA UDI
    Oticon A/S·05707131262332·H10, RITE 312 WL CBE

    DreamWear Full

    FDA UDI
    Respironics, Inc.·00606959046207·Small Medium, DreamWear Full Face Mask, Small F...

    REVOLIX LASER SYSTEMS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MIS ANTERIOR CERVICAL PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GMK SPHERE FEMORAL COMPONENT SIZE 2 RIGHT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 29, 2014

    JETSTREAM SC

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MCW·January 31, 2023

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 29, 2013

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·June 15, 2011

    HIRES 90K

    FDA Adverse Event
    Malfunction ·ADVANCED BIONICS CORP.·Product code MCM·August 22, 2008

    Philips Respironics DreamWear Full Face Mask

    FDA Enforcement
    Class I ·Ongoing·Philips Respironics, Inc.·October 12, 2022

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    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