BEUDAMED
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    FibroScan 430 Mini+

    FDA 510(k)
    FDA Class 2 ·Radiology

    Symmetry Surgical

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482056851·Symmetry® Forceps, Mosquito, 9 1/4 in

    S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 11, 2013

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·June 24, 2011

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code NIQ·September 18, 2008

    Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution

    FDA Enforcement
    Class II ·Terminated·Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical·June 12, 2019

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020

    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