BEUDAMED
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    Encore Medical Inc.

    Manufacturer
    🇺🇸 United States

    OSTEOIMPLANT TECHNOLOGIES INC. HIP SYSTEM

    FDA Adverse Event
    Injury ·OSTEOIMPLANT TECHNOLOGIES INC./PINNACLE HOLDING·Product code LPH·March 18, 2009

    *

    FDA Adverse Event
    Injury ·PINNACLE HOLDING INC·Product code KWB·July 9, 2008

    HIP STEM

    FDA Adverse Event
    Injury ·OTI/PINNACLE HOLDING, INC·Product code KWY·July 9, 2008

    TIBIAL INSERT, #5 ANATOMIC

    FDA Adverse Event
    Injury ·OSTEOIMPLANT TECHNOLOGIES, INC/PINNACLE HOLDING·Product code HSH·July 9, 2008

    UNKNOWN KNEE

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code JWH·July 11, 2012

    LIMA HIP

    FDA Adverse Event
    Malfunction ·ENCORE MEDICAL, L.P.·Product code HXC·June 21, 2012

    LIMA HIP

    FDA Adverse Event
    Malfunction ·ENCORE MEDICAL, L.P.·Product code LXH·June 21, 2012

    ENCORE

    FDA Adverse Event
    Death ·MEDIBO MEDICAL PRODUCTS NV·Product code FSA·May 3, 2012

    *

    FDA Adverse Event
    STRYKER HOWMEDICA·Product code JWH·September 7, 2004

    J2-HS CENTRIFUGE

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JQC·June 16, 2011

    RXVTU-1

    FDA Adverse Event
    Malfunction ·ENCORE MEDICAL INC·Product code NHU·January 4, 2002

    MDSS GmbH

    Authorized representative
    🇩🇪 Germany·388 Manufacturers·16562 Devices

    Advena Limited

    Authorized representative
    🇲🇹 Malta·467 Manufacturers·13717 Devices

    TrueBeam Linear Accelerators (aka Trilogy Mx) Varian Medical Systems, Palo Alto, CA Product Usage: Intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors , and conditions anywhere in the body where radiation treatment is indicated.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·May 19, 2011

    Cholestech LDX Lipid Profile"GLU test cassettes, Catalog Number 10-991, Lot # 245104 Cholestech LDX Lipid-Glucose tests are intended for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides, and/or glucose in whole blood, serum, and plasma. A TC/HDL (total cholesterol/HDL cholesterol) ratio and estimated values for LDL (lowdensity lipoprotein) and non-HDL cholesterol are calculated by the Cholestech LDX.

    FDA Recall
    Terminated ·Biosite Inc Dba Innovacon Inc.·Product code CGA·February 18, 2011

    Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5 are quality control materials that are used to assist the laboratory in monitoring test performance throughout the measurable range. They are not calibrators and are not used to calibrate the Triage tests. The results of quality control testing do not impact direct patient care and should not influence clinical decision making process the physician uses to make clinical diagnosis for the patient. Indications for Use: The Alere Triage Total 5 Controls are assayed materials to be used with the Alere Triage Cardiac Panel, Alere Triage CardioProfiler Panel, Alere Triage Profiler SOB Panel, Alere Triage BNP Test, Alere Triage D-Dimer Test, and Alere Triage Meters to assist the laboratory in monitoring test performance.

    FDA Recall
    Terminated ·Alere San Diego, Inc.·Product code JJY·October 12, 2016

    Prolinx GmbH

    Authorized representative
    🇩🇪 Germany·97 Manufacturers·1780 Devices

    CMC Medical Devices & Drugs SL

    Authorized representative
    🇪🇸 Spain·698 Manufacturers·11260 Devices