BEUDAMED
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    Responsive Arthroscopy Wedge Push-In Suture Anchors

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Pre-Finisher

    FDA UDI
    TP ORTHODONTICS INC·00192029042106·4 Bicuspid Extraction

    ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CIRCUFLOW 5100 SEQUENTIAL COMPRESSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 21, 2014

    2520274-2013-03825

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·June 26, 2013

    EXPECT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code ODG·August 4, 2011

    EXACTECH

    FDA Adverse Event
    Malfunction ·EXACTECH, INC.·Product code LXH·April 4, 2022

    EXACTECH

    FDA Adverse Event
    Malfunction ·EXACTECH, INC.·Product code LHX·April 1, 2022

    EXACTECH

    FDA Adverse Event
    Malfunction ·EXACTECH, INC.·Product code LXH·April 26, 2022

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    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 REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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