BEUDAMED
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    Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A - Product Usage: The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.

    FDA Enforcement
    Class II ·Completed·Bio-Rad Labs·May 6, 2020

    LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent.

    FDA Recall
    Completed ·Smith & Nephew, Inc.·Product code JWH·January 15, 2018

    LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent.

    FDA Enforcement
    Class II ·Completed·Smith & Nephew, Inc.·September 18, 2019

    ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605

    FDA Enforcement
    Class II ·Completed·SCIENCE & BIO MATERIALS·July 20, 2022

    6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.

    FDA Enforcement
    Class II ·Completed·Chromsystems Instruments & Chemicals GmbH·December 9, 2020

    MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.

    FDA Enforcement
    Class II ·Completed·Chromsystems Instruments & Chemicals GmbH·December 9, 2020

    MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.

    FDA Enforcement
    Class II ·Completed·Chromsystems Instruments & Chemicals GmbH·December 9, 2020

    Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, Angled 6 units, Individual Packaging Label: ProTekt Sharps Safety Knives - REF: PG 44620MU,2.2mm double Bevel Slit, Sterile R, Angled 1 unit, Handle Labeling; 2.5mm slit double bevel

    FDA Recall
    Completed ·International Science & Technology, LP, DBA Diamatrix Ltd.·Product code HNN·February 24, 2022

    Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72

    FDA Recall
    Completed ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code NVY·November 8, 2021

    Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator

    FDA Recall
    Completed ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code NVZ·November 8, 2021

    LINQ II Insertable Cardiac Monitor

    FDA Recall
    Completed ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code MXD·January 18, 2022

    ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605

    FDA Recall
    Completed ·SCIENCE & BIO MATERIALS Zi Du Monge Lourdes France·Product code HWC·October 7, 2021

    Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, Angled 6 units, Individual Packaging Label: ProTekt Sharps Safety Knives - REF: PG 44620MU,2.2mm double Bevel Slit, Sterile R, Angled 1 unit, Handle Labeling; 2.5mm slit double bevel

    FDA Enforcement
    Class II ·Completed·International Science & Technology, LP, DBA Diamatrix Ltd.·June 1, 2022

    MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.

    FDA Recall
    Completed ·Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany·Product code JJY·October 29, 2020

    MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.

    FDA Recall
    Completed ·Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany·Product code JJY·October 29, 2020

    6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.

    FDA Recall
    Completed ·Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany·Product code JIX·October 29, 2020