BEUDAMED
    67 results · 13ms · Sources: EU EUDAMED, US FDA

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    GEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 29, 2015

    HiSpeed LX/l (2200997-2)

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAK·February 1, 2010

    Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #882470 and Model #882473; GEMINI TF 64 - Model #882471, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning systems, diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 6, 2013

    T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal protection garment

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·May 2, 2018

    T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100 Sterile personal protection garment

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·May 2, 2018

    T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal protection garment

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FYA·February 23, 2018

    T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garment

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FYA·February 23, 2018

    Gemini LXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·March 6, 2015

    GEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·July 1, 2015

    T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garment

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·May 2, 2018

    Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476)

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·December 4, 2013

    Gemini LXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100 Sterile personal protection garment

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FYA·February 23, 2018

    Dressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.

    FDA Enforcement
    Class II ·Terminated·Breg Inc·May 10, 2017

    Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body computed tomography (CT) x-ray systems or sub-systems, each with a continuously rotating x-ray tube and multi-row detectors enclosed by a gantry. X-ray transmission data acquired and taken at different angles can be reconstructed into cross-sectional images. Each device also includes signal analysis and display equipment, patient and equipment supports, components, and accessories.

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·April 24, 2013

    Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013

    ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.

    FDA Recall
    Terminated ·ulrich medical USA Inc·Product code LXL·March 8, 2019

    Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476)

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 12, 2014

    Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FYA·May 23, 2013

    Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FYA·May 23, 2013