BEUDAMED
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    Tempa DOT Single-Use Clinical Thermometer Medical Indicators Made in U.S.A. by Medical Indicators, Inc. 16 Thomas J Rhodes Industrial Drive, Hamilton, NJ 08619 USA Phone 1.888.737.1601 www.medicalindicators.com Per 3M website (this product line was recently bought by Medical Indicators from 3M) and labeling in 806, TempaDOT thermometers are individually wrapped, single-use, disposable clinical thermometers for oral or axillary use.

    FDA Recall
    Terminated ·Medical Indicators, Inc.·Product code FQZ·July 10, 2013

    Merit Medical Systems, Inc. Medallion Syringe REF/CAT No.: MSS111-LB Indicated for use in cardiology and radiology procedures.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code FMF·September 29, 2009

    ACUSON S1000 ultrasound systems running software version 1.0, Siemens Medical Solutions, USA, Inc. Mountain View, CA. The product is indicated for use as an ultrasound imaging system.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYN·April 25, 2012

    CyberKnife Robotic Radiosurgery System, medical charged-particle radiation therapy system, manufactured by Accuray Inc., Sunnyvale, CA. Indicated for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Recall
    Terminated ·Accuray Inc·Product code IYE·October 28, 2010

    CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System radiation therapy device, manufactured by Accuray Inc., Sunnyvale, CA. Medical device indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Recall
    Terminated ·Accuray Inc·Product code MUJ·July 6, 2010

    Varian brand Clinac and TrueBeam, High Energy Linear Accelerator, Model Numbers: H14, H19, H29; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·March 31, 2011

    Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display cross sectional volumes of the whole body, to include the head.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·April 25, 2016

    Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation Framework (DCF) 8.2.22, model number H48, manufactured by Varian Medical Systems, Inc., Palo Alto, CA. Indicated for planning proton treatment of neoplasms of the eye.

    FDA Recall
    Terminated ·Varian Medical Systems Oncology Systems·Product code MUJ·October 2, 2008

    ICU Medical, Inc. Cath Lab Kit W/3Port "ON" Manifold, Waste Bag, Syringe & TP4; Item Number: AG7843 Indicated for fluid flow directional control and for providing access port(s) for administration of solutions.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code FMG·June 11, 2008

    Clinac, Trilogy. Trilogy Tx and Novalis Tx Linear Accelerators. Varian Medical Systems, Inc. Oncology Systems Intended for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions in the body where radiation treatment is indicated.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·May 26, 2011

    Freestyle Navigator Continuous Glucose Monitor System, Clinical Transmitter, Abbott Item Number: PRT 03831-091, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.

    FDA Recall
    Terminated ·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009

    Freestyle Navigator Continuous Glucose Monitor System, ABB Transmitter Navigator. Abbott Item Number: PRT 03831-001, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.

    FDA Recall
    Terminated ·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009

    Freestyle Navigator Continuous Glucose Monitor System, System Kit, Business 1, (Orange). Abbott Item Number: PRT 03415-001, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.

    FDA Recall
    Terminated ·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009

    Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, Replacement Kit, Transmitter, Abbott Item Number 70791-02, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.

    FDA Recall
    Terminated ·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009

    Freestyle Navigator Continuous Glucose Monitor System, Clinical System Kit, Packaging. Abbott Item Number: PRT 03415-010, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.

    FDA Recall
    Terminated ·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009

    Freestyle Navigator Continuous Glucose Monitor System, Assy, Transmitter Poly Contac, Abbott Item Number: PRT 03831-002, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.

    FDA Recall
    Terminated ·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009

    Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, SYSTEM KIT PACKAGING , Abbott Item Number 70684-03, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.

    FDA Recall
    Terminated ·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009

    GreenLight MoXy Fiber Optic, part number 0010-2400, for use with the GreenLight XPS Laser System, manufactured by American Medical Systems Inc., San Jose, CA The XPS Laser system is indicated for surgical incision and excision, vaporization, ablation, hemostasis and coagulation of soft tissue.

    FDA Recall
    Terminated ·AMS Innovative Center San Jose·Product code GEX·July 14, 2010

    ENDO-FUSE(TM) FUSION ROD, 7 mm X 70 mm IMPLANT MATERIAL: STERILE R, Ti6A14V, CPTi, REF: 500005970, LOT 088605422, Wright Medical Technology, Inc , 5877 Airline Road, Arlington, TN 38002 The ENDO-FUSE(R) Intra-Osseous Fusion Rods are indicated for the reduction and fixation of fractures. They are indicated for the integral fixation of fractures, bony fusions, and non-unions. They are also indicated for reconstructive procedures where reduction and fixation of bone fragments are required (e.g. osteotomies).

    FDA Recall
    Terminated ·Wright Medical Technology Inc·Product code HWC·April 20, 2011

    Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit Business I, MG,(E). Abbott Item Number 70965-02, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.

    FDA Recall
    Terminated ·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009