BEUDAMED
    32 results · 6ms · Sources: EU EUDAMED, US FDA

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

    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

    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 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

    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

    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

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

    VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria.

    FDA Enforcement
    Class II ·Terminated·Biomerieux Inc·March 31, 2021

    AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    AAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575EL

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    AAMI 3 FABRIC REINF SURG GOWN 2XL, Item Code 9571

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    VITEK 2 XL computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbished), Cat. #W0452R; (3) rp5800 XPE, Cat. 413642; (4) rp5800 WES7, Cat. #413862; (5) dc7100 8-port, Cat. #W0441; (6) dc7100 8-port (refurbished), Cat. #W0441R; (7) dc7700 8-port, Cat. #W0447; (8) dc7700 8-port (refurbished), Cat. #W0447R; (9) dc7800, Cat. #W0449; and (10) dc7800 (refurbished), Cat. #W0449R. VITEK 2 is an automated system designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.

    FDA Enforcement
    Class II ·Terminated·Biomerieux Inc·April 3, 2013

    Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 36 MM, +3MM Standard Product Usage: is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·June 3, 2020