BEUDAMED
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    VITA RESPONSE

    FDA 510(k)
    FDA Class 2 ·Dental

    PowerPICC SOLO

    FDA UDI
    Bard Access Systems, Inc.·00801741121111·Catheter Placement Kit

    CUSTOM PROCEDURE KIT

    FDA UDI
    MEDIVATORS INC.·40677964004863·CUSTOM PROCEDURE KIT

    CARDIOSAVE HYBRID, TYPE B PLUG

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·February 12, 2025

    CORTEK CYSTOSCOPE

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

    GSI 2000 MIDDLE EAR ANALYZER

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

    SURGITEK BREAST IMPLANT, 255 SIZE 11

    FDA Adverse Event
    MEDICAL ENGINEERING CORP.·Product code FTR·February 2, 1994

    BREAST IMPLANT, 175 CC

    FDA Adverse Event
    DOW CORNING CORP.·Product code FTR·February 2, 1994

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·March 12, 2013

    ALARIS PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FPA·February 2, 2011

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·February 21, 2008

    PRECISION SPECTRA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 12, 2020

    BrightView SPECT (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 SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013

    BrightView, Gamma Camera System, Product Code 882480.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·January 17, 2024

    BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 9, 2016

    882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors).

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

    BrightView SPECT, Model Number 882480

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 31, 2019

    BrightView Model 882480 Product Usage: 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).

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 14, 2018

    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