BEUDAMED
    13 results · 26ms · Sources: EU EUDAMED, US FDA

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    VARIABLE HIGH FLOW DOWNS CPAP GENERATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    N.A.

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011861104220·Standard Band, Tooth 44/34, Size 4/Roth 22

    N.A.

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011861104180·Standard Band, Tooth 44/34, Size 4/Roth 18

    N.A.

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011861104000·Standard Band, Tooth 45-44/34-35, Size 4

    SPEECHLINK 100 TYPE 1053

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ADULT SWIVEL FORK

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    MALLORY/HEAD - PF ACETABULAR COMPONENT

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDI·March 8, 2017

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 10, 2014

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·October 4, 2010

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 4, 2012

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024

    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012