BEUDAMED
    37 results · 21ms · Sources: EU EUDAMED, US FDA

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    RENEGADE HI-FLO MICROCATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    truFreeze

    FDA UDI
    US Endoscopy·00724995199227·Rapid AV Catheter Kit with 20 FR CDT includes 2...

    truFreeze

    FDA UDI
    Csa Medical, Inc.·00857068006143·Rapid AV Kit with 20 Fr CDT (5 pack)

    truFreeze

    FDA UDI
    Csa Medical, Inc.·00857068006099·Rapid Av Active Venting Spray Kit - 5 Rapid AV ...

    Responsive Respiratory, Inc.

    FDA UDI
    RESPONSIVE RESPIRATORY, INC.·00851440007544·Cylinder Wrench with Bungee, CGA 870, Plastic, ...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450155134·

    QB1 NMES Electrode Set

    FDA UDI
    Motive Health, Inc.·00854816006967·QB1 NMES Electrode Set

    STERIS AMSCO MILLENNIUM STEAM STERILIZER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    LINER: MPACT FLAT PE HC LINER 32/C

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·December 29, 2020

    COUPLER AC ZOOM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code FEM·July 15, 2020

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·August 6, 2021

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·March 12, 2013

    ST104 TRANSPORT

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

    GORE TAG THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES, INC.·Product code MIH·February 18, 2008

    BrightView SPECT model number 882480 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·April 12, 2017

    Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D: INT1-D001-MG PT-000011 M/D: INT1-D001-MM UDI 10385082000009 The Omnipod DASH Personal Diabetes Manager (PDM) is a mobile, handheld Android device that is intended to communicate with the Omnipod DASH Pod (pump).

    FDA Enforcement
    Class II ·Terminated·Insulet Corporation·April 1, 2020

    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