BEUDAMED
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    EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096

    FDA Recall
    Open, Classified ·Product code LXH·February 4, 2019

    Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLOCN304L, VLOCN306L, VLOCN308L

    FDA Recall
    Open, Classified ·Product code GAM·September 28, 2022

    Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code JAK·January 19, 2019

    SURG PAT XRAY 1X3 Model/Catalog Number: 801408. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBA·September 20, 2024

    SURG PAT XRAY 1X1 Model/Catalog Number: 801403. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBA·September 20, 2024

    SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBA·September 20, 2024

    SURG PAT XRAY 1/2X3 Model/Catalog Number: 801407. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBA·September 20, 2024

    SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBA·September 20, 2024

    SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBA·September 20, 2024

    SURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBA·September 20, 2024

    SURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBA·September 20, 2024

    SURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBA·September 20, 2024

    SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBA·September 20, 2024

    SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBA·September 20, 2024

    SURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBA·September 20, 2024

    Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-FR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A

    FDA Recall
    Open, Classified ·Hitachi America, Ltd., Particle Therapy Division·Product code LHN·May 27, 2024

    Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-CR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A

    FDA Recall
    Open, Classified ·Hitachi America, Ltd., Particle Therapy Division·Product code LHN·May 27, 2024

    Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A

    FDA Recall
    Open, Classified ·Hitachi America, Ltd., Particle Therapy Division·Product code LHN·May 27, 2024

    Description/REF: PICC ACCESS TRAY/ASK-04001-CG1

    FDA Recall
    Open, Classified ·ARROW INTERNATIONAL, LLC·Product code LJT·April 21, 2026

    smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4173-24

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code LJT·February 13, 2025