BEUDAMED
    85 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    Screw Tap Tapered WP Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·February 26, 2020

    Drill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·February 26, 2020

    Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·February 26, 2020

    Drill Tapered RP 4.3x13 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·February 26, 2020

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

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, Lp·December 18, 2019

    Dense Bone Drill 6.0 6x16 mm Single-Pat- Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·February 26, 2020

    Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·February 26, 2020

    Drill Tapered RP 4.3x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·February 26, 2020

    Drill Tapered 6.0 6x8 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·February 26, 2020

    Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·February 26, 2020

    Drill Tapered NP 3.5x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·February 26, 2020

    Drill Tapered WP 5x11.5 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·February 26, 2020

    Dense Bone Drill NP 3.5x16 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·February 26, 2020

    Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·February 26, 2020

    12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy system.

    FDA Enforcement
    Class II ·Terminated·Ion Beam Applications S.A.·June 13, 2018

    728332 IQon Spectral CT-Computed Tomography X-ray system

    FDA Enforcement
    Class II ·Terminated·Philips North America Llc·August 25, 2021

    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 Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·November 6, 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 Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·November 6, 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 Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·November 6, 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 Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·November 6, 2024