BEUDAMED
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    INSIGHT 4000 ENDOSCOPE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Affiniti

    FDA UDI
    TORNIER, INC.·00846832024636·HUMERAL HEAD TRIAL

    PowerPICC

    FDA UDI
    Bard Access Systems, Inc.·00801741043727·Catheter Placement Kit

    SR Facebow

    FDA UDI
    ORMCO CORPORATION·00889989023374·Facebow MINI-VEC SZ 2 .050 DIA

    intellijoint HIP®

    FDA UDI
    Intellijoint Surgical Inc·00628184002520·CCU, G2

    MIXING CONNECTOR WITH SPRAY TIP

    FDA Adverse Event
    Injury ·MICROMEDICS, INC.·Product code FMF·February 7, 2020

    e-vive BILATERAL NMES SYSTEM; LARGE / XL (2.0 Dock)

    FDA UDI
    Motive Health, Inc.·00854691008544·e-vive BILATERAL NMES SYSTEM; LARGE / XL (2.0...

    QB1 NMES SYSTEM, BILATERAL, LARGE/XLARGE

    FDA UDI
    Motive Health, Inc.·00854691008704·QB1 NMES SYSTEM, BILATERAL, LARGE/XLARGE

    X-RAY MONOBLOCK, MONOBLOCK XRS-60-330

    FDA 510(k)
    FDA Class 1 ·Radiology

    KIPPMED I.V. MANIFOLD

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RD SET GE - 12

    FDA Adverse Event
    Malfunction ·Product code DQA·August 13, 2021

    LIMA HIP

    FDA Adverse Event
    ENCORE MEDICAL, L.P.·Product code LWJ·March 12, 2013

    LD304 MATERNITY BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code HDD·February 3, 2011

    FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MCX·February 14, 2008

    AUTOMATED IMPELLA CONTROLLER

    FDA Adverse Event
    Malfunction ·ABIOMED, INC·Product code OZD·May 6, 2025

    HLS SET

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DTZ·June 16, 2025

    Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 5, 2014

    BrightView XCT model number 882482 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only). BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with an x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and BrightView XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data. The BrightView XCT imaging system should only be used by trained healthcare professionals.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 12, 2017

    BrightView XCT (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

    BrightView XCT

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 22, 2017