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    TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS

    FDA 510(k)
    FDA Class 2 ·Dental

    Oticon

    FDA UDI
    Oticon A/S·05707131260468·RIA PRO, BTE 13 WL 100 CBE DEMO

    AUVON RECHARGEABLE TENS UNIT MUSCLE STIMULATOR

    FDA Adverse Event
    Injury ·SHENZHEN AS-TEC TECHNOLOGY CO., LTD·Product code NGX·January 27, 2025

    SEA-BAND

    FDA 510(k)
    FDA Unclassified ·Unknown

    OMNI EXPRESS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 25, 2015

    ARTICULEZE M HEAD 36MM -2

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 29, 2013

    SPACEMAKER PREPERITONEAL DIST BALLOON

    FDA Adverse Event
    Malfunction ·USSC PUERTO RICO·Product code GCJ·May 11, 2011

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    JUMAO HEALTHCARE EQUIPMENT·Product code IOR·October 1, 2014

    AUVON TENS UNIT

    FDA Adverse Event
    Injury ·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·December 19, 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

    Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020