BEUDAMED
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    TANDEM ASSEMBED 3&4 WAY STERILE STOPCKS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VITROS

    FDA UDI
    ORTHO CLINICAL DIAGNOSTICS·10758750000913·VITROS Immunodiagnostic Products AFP Calibrators

    SCANLAN® V.I.P™ Instrument Sterilization Trays

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159010930·replacement tray

    ACUMED

    FDA UDI
    Acumed LLC·10806378045363·Lower Extremity Lag Screw Tray

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209106585·

    Tiger® Occipital-Cervical-Thoracic Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REPLACEMENT HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·May 8, 2014

    IMPLANT PDS3000 6PK PILLAR PALATAL EN

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC.·Product code LRK·October 17, 2012

    PFC SIGMA CRVD INSERT SZ3 8MM

    FDA Adverse Event
    Injury ·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code JWH·August 10, 2010

    VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Products AFP Calibrators, Unique Device Identifier No. 10758750000913, REF 680 0863, were included in the communication because they are lot-linked to the Reagent Packs and cannot be used with any other lot of reagent. There is no known failure with the Calibrators. For the quantitative measurement of alpha-fetoprotein (AFP) concentrations in human serum using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the management of patients with non-seminomatous testicular cancer.

    FDA Enforcement
    Class III ·Terminated·ORTHO-CLINICAL DIAGNOSTICS·July 20, 2016

    VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Products AFP Calibrators, Unique Device Identifier No. 10758750000913, REF 680 0863, were included in the communication because they are lot-linked to the Reagent Packs and cannot be used with any other lot of reagent. There is no known failure with the Calibrators. For the quantitative measurement of alpha-fetoprotein (AFP) concentrations in human serum using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the management of patients with non-seminomatous testicular cancer.

    FDA Recall
    Terminated ·ORTHO-CLINICAL DIAGNOSTICS FELINDRE MEADOWS Bridgend United Kingdom·Product code LOJ·May 9, 2016

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021