BEUDAMED
    106 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Completed × Clear all

    INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup

    FDA Enforcement
    Class II ·Completed·Innomed, Inc.·May 8, 2024

    Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, Sold as Rehab Tough and Tilt (TNT), Rehab Recline and Mobility (RAM), Rehab Kidster (Kidster). Provide mobility to individuals limited to a seating position.

    FDA Enforcement
    Class II ·Completed·CHENICA INC.·February 20, 2013

    Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a total of 6 trials/tray: (1) HAT STD Left Tray Trial, Cat. #321-00-01; (2) HAT STD Right Tray Trial, Cat. #321-00-02; (3) HAT LAT Left Tray Trial, Cat. #321-00-11; (4) HAT LAT Right Tray Trial, Cat. #321-00-12; (5) HAT EXT LAT Left Trial, Cat. #321-00-21; and (6) HAT EXT LAT Right Trial, Cat. #321-00-22. The Humeral Augmented Tray is designed to function with the Equinoxe Reverse Shoulder System orthopedic implant components.

    FDA Enforcement
    Class II ·Completed·Exactech, Inc.·July 7, 2021

    Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870 Single Kit P/N: K6870.20.US.L 20 Plates

    FDA Enforcement
    Class II ·Completed·IMMUNDIAGNOSTIK, Inc·May 24, 2023

    Medtronic SynchroMed, Model A10

    FDA Enforcement
    Class II ·Completed·Medtronic Inc.·December 20, 2023

    iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101

    FDA Enforcement
    Class II ·Completed·Conformis, Inc.·April 20, 2022

    Destino Twist 14F (also branded as Guidestar 14F)

    FDA Enforcement
    Class II ·Completed·Oscor Inc.·February 23, 2022

    Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.

    FDA Enforcement
    Class II ·Completed·Medtronic Inc.·January 10, 2024

    Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.

    FDA Enforcement
    Class II ·Completed·Exactech, Inc.·August 18, 2021

    Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.

    FDA Enforcement
    Class II ·Completed·Exactech, Inc.·August 18, 2021

    AggreGuide A-100 Instrument

    FDA Enforcement
    Class II ·Completed·Aggredyne, Inc.·September 7, 2022

    Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101

    FDA Enforcement
    Class II ·Completed·Hologic, Inc·December 18, 2024

    NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software

    FDA Enforcement
    Class II ·Completed·Illumina, Inc.·June 28, 2023

    illumina Model NextSeq 550 Dx REF 20005715

    FDA Enforcement
    Class II ·Completed·Illumina, Inc.·June 22, 2022

    illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx

    FDA Enforcement
    Class II ·Completed·Illumina, Inc.·June 22, 2022

    CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.

    FDA Enforcement
    Class II ·Completed·Caire, Inc.·November 27, 2024

    MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.

    FDA Enforcement
    Class II ·Completed·Illumina, Inc.·June 28, 2023

    Illumina NextSeq 550Dx, REF: 20005715, CE, IVD

    FDA Enforcement
    Class II ·Completed·Illumina, Inc.·April 6, 2022

    CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.

    FDA Enforcement
    Class II ·Completed·Caire, Inc.·November 27, 2024

    CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.

    FDA Enforcement
    Class II ·Completed·Caire, Inc.·November 27, 2024