BEUDAMED
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    A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution, and delivering the sample to the cartridge.

    FDA Recall
    Completed ·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·Product code LCP·September 18, 2024

    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

    FDA Enforcement
    Class II ·Completed·Encore Medical, Lp·April 4, 2018

    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

    FDA Enforcement
    Class II ·Completed·Encore Medical, Lp·April 4, 2018

    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

    FDA Enforcement
    Class II ·Completed·Encore Medical, Lp·April 4, 2018

    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

    FDA Enforcement
    Class II ·Completed·Encore Medical, Lp·April 4, 2018

    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

    FDA Enforcement
    Class II ·Completed·Encore Medical, Lp·April 4, 2018

    REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2

    FDA Enforcement
    Class II ·Completed·Encore Medical, LP·January 10, 2024

    Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797

    FDA Enforcement
    Class II ·Completed·Encore Medical, LP·January 10, 2024

    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

    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