BEUDAMED
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    ICON 9.5 Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code JWM·February 10, 2003

    Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·April 2, 2014

    Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow cells (MiSeqDx Universal Kit 1.0), imaging hardware, and data analysis software. The MiSeqDx Platform is intended for targeted sequencing of human genomic DNA from peripheral whole blood samples.

    FDA Enforcement
    Class II ·Terminated·Illumina Inc·September 17, 2014

    SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System

    FDA Enforcement
    Class II ·Terminated·Pega Medical Inc.·August 21, 2019

    DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.

    FDA Enforcement
    Class II ·Terminated·DePuy Spine, Inc.·March 27, 2013

    Terumo Advanced Perfusion System 1 Base, 220/240V, Catalog 801764, 6 " Roller Pump Occlusion: Reference AA-2011-015 C. indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·March 16, 2012

    Terumo Advanced Perfusion System 1 Base, 100/120V, Catalog 801763, 6 " Roller Pump Occlusion: Reference AA-2011-015 C. Indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·March 16, 2012

    DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.

    FDA Enforcement
    Class II ·Terminated·DePuy Spine, Inc.·March 27, 2013

    DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.

    FDA Enforcement
    Class II ·Terminated·DePuy Spine, Inc.·March 27, 2013

    DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.

    FDA Enforcement
    Class II ·Terminated·DePuy Spine, Inc.·March 27, 2013

    EasyFuse Dynamic Compression System Instrument Pack

    FDA Enforcement
    Class II ·Terminated·Wright Medical Technology, Inc.·April 6, 2022

    Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France Used to facilitate insertion of the Aero-AL cage into the disc space.

    FDA Enforcement
    Class II ·Terminated·Stryker Spine·March 2, 2016

    Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna.

    FDA Recall
    Terminated ·Synthes, Inc.·Product code HRS·January 7, 2014

    ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code GKZ·August 12, 2013

    Stryker Xia Precision System; Jam Shidi 10 Gauge 5 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ. Intended for use as a manual surgical instrument during percutaneous posterior, non-cervical pedicle fixation.

    FDA Recall
    Terminated ·Stryker Spine·Product code LXH·January 18, 2010

    Stryker Xia Precision System; Jam Shidi 10 Gauge 9 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ. Intended for use as a manual surgical instrument during percutaneous posterior, non-cervical pedicle fixation.

    FDA Recall
    Terminated ·Stryker Spine·Product code LXH·January 18, 2010

    Zimmer Dynesys top-loading cutter, spacer, Zimmer Spine, Minneapolis, MN; REF 07.01284.001.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code NQP·May 28, 2009

    Stryker Xia Precision System; Jam Shidi 13 Gauge 5 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ. Intended for use as a manual surgical instrument during percutaneous posterior, non-cervical pedicle fixation.

    FDA Recall
    Terminated ·Stryker Spine·Product code LHX·January 18, 2010

    Stryker Xia Precision System; Jam Shidi 11 Gauge 5 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ. Intended for use as a manual surgical instrument during percutaneous posterior, non-cervical pedicle fixation.

    FDA Recall
    Terminated ·Stryker Spine·Product code LXH·January 18, 2010

    Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·April 8, 2015