BEUDAMED
    27 results · 28ms · Sources: EU EUDAMED, US FDA

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    SHUTTLE STOP

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092116609·NobelBiocare™ Tri-Lobe-compatible RP 30° Multi-...

    CUSTOM PROCEDURE KIT

    FDA UDI
    MEDIVATORS INC.·40677964004948·The ENDO CARRY-ON Procedure Kit contains all of...

    PenEvac1

    FDA UDI
    I.C. MEDICAL, INC.·00817688022862·PenEvac1®, Megadyne E-Z Clean Blade, 10’ Tube, ...

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 30, 2026

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 30, 2026

    MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO

    FDA 510(k)
    FDA Class 2 ·Immunology

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·December 27, 2016

    PROMUS ELEMENT ¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·March 12, 2013

    SYSTEM 5 SINGLE TRIGGER ROTARY HANDPIECE

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·February 1, 2011

    6800

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

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·December 22, 2021

    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