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

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305

    FDA Enforcement
    Class II ·Ongoing·Fujifilm Irvine Scientific, Inc.·April 5, 2023

    Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom) Powered stretcher

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·March 23, 2016

    Transport Stretcher, and Head and Neck Surgery Stretcher Non-powered stretcher

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·March 23, 2016

    Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil

    FDA Enforcement
    Class II ·Terminated·Rainbow Specialty & Health Products·December 30, 2015

    Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integris Allura 15 & 12 (monoplane) (722043), INTEGRIS Allura 15-12 (biplane) (722044), Integris-Allura 9 (722018), Integris-Allura 9 (Biplane) (722021), Integris CV Cesar-Powerpack (722030), Integris H5000 C / Allura 9C (722016);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026

    NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD***ADDRESS: NEUSOFT PARK, HUNNAN INDUSTRIAL AREA, SHENYANG***CHINA***".

    FDA Enforcement
    Class II ·Terminated·Philips And Neusoft Medical Systems Co., Ltd.·August 1, 2012

    MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·September 26, 2012

    AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses

    FDA Enforcement
    Class II ·Terminated·Cooper Vision Caribbean Corp.·January 9, 2013

    MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010

    FDA Enforcement
    Class II ·Ongoing·KOB GmbH·March 18, 2026

    GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·May 8, 2013

    Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·July 19, 2023

    Brilliance Big Bore Radiology 728244

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 4, 2018

    Shimadzu X-ray High Voltage Generator Model No. UD150B-40 on SONIALVISION safire II/17 systems with 0.7/1.2JG326D X-Ray Tube Diagnostic x-ray high voltage generator.

    FDA Enforcement
    Class II ·Terminated·Shimadzu Medical Systems·January 4, 2017

    Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 3, 2025

    Ingenuity TF PET/CT 882442

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 4, 2018

    Shimadzu X-ray TV System, Catalog No. SONIALVISION G4

    FDA Enforcement
    Class II ·Terminated·Shimadzu Medical Systems·January 4, 2017

    Philips Ingenuity Core 728321

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 4, 2018

    Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), Philips Healthcare Systems, Cleveland, OH. The Brilliance 6, 16 and MX8000 Dual v. Exp are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. GEMINI Dual is an imaging system that combines positron emission tomography (PET) and X-ray computed tomography. The GEMINI produces attenuation and non-attenuation corrected images of the distribution of PET radiopharmaceuticals in the head, body and total body as well as X-ray transmission images of these areas. The PET and CT images are registered and displayed in a fused format to provide combined PET and anatomical data at different angles for interpretation by trained health professionals. The PET and CT portions of the system can be used either as an integrated system or as a stand-alone PET or CT system. GEMINI can provide CT data suitable for use in attenuation correction.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·October 3, 2012

    Ingenuity Core128 728323

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 4, 2018

    Ingenuity Core128/Elite China 728324

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 4, 2018