BEUDAMED
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    TRITEST CONTROL REAGENT IGG1 FITC/IGFG1 PE/CD45 PERCP

    FDA 510(k)
    FDA Class 2 ·Hematology

    BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 20, 2024

    Acetabular reamer ø57mm

    FDA UDI
    Incipio Devices SA·07630055302830·Acetabular reamer for hip arthroplasty

    RESORBABLE BONE SCREW

    FDA UDI
    Biomet Orthopedics, LLC·00880304416338·

    COULTER LH 750 HEMATOLOGY ANALYZER

    FDA 510(k)
    FDA Class 2 ·Hematology

    DU PONT TOBRAMYCIN ASSAY CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    NexGen®

    FDA UDI
    Zimmer, Inc.·00889024207172·

    NexGen®

    FDA UDI
    Zimmer, Inc.·00889024207196·

    NexGen®

    FDA UDI
    Zimmer, Inc.·00889024207189·

    NexGen®

    FDA UDI
    Zimmer, Inc.·00889024207165·

    MINICAP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - CUERNAVACA·Product code KDI·February 8, 2013

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·December 7, 2010

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 22, 2014

    NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 7 sterile, REF 00-5950-057-01, Zimmer Inc. Warsaw, IN. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code JWH·April 26, 2010

    NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 8, sterile, REF 00-5950-057-02, Zimmer Inc. Warsaw, IN. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code JWH·April 26, 2010

    NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 9, sterile, REF 00-5950-057-03, Zimmer Inc. Warsaw, IN. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code JWH·April 26, 2010

    NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 10, sterile, REF 00-5950-057-04, Zimmer Inc. Warsaw, IN. This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code JWH·April 26, 2010

    IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 20, 2014