BEUDAMED
    27 results · 19ms · Sources: EU EUDAMED, US FDA

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    ERS RADIAL HEAD REPLACEMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PowerPICC

    FDA UDI
    Bard Access Systems, Inc.·00801741129636·Catheter Placement Kit

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040054489·Strip Crown Forms

    LEGION

    FDA UDI
    Smith & Nephew, Inc.·00885556766606·LEGION TRIAL STEM 17MM X 160MM

    LEGION

    FDA UDI
    Smith & Nephew, Inc.·00885556766613·LEGION REAMER 17MM

    LEGION

    FDA UDI
    Smith & Nephew, Inc.·00885556766590·LEGION PRESSFIT STEM 17MM X 160MM

    VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9

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

    BROTHERS POWDER-FREE VINYL EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CARDIOSAVE HYBRID TYPE B PLUG

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - MAHWAH·Product code DSP·February 14, 2022

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·March 12, 2013

    TRAJECTORY GUIDE KIT, BIOPSY, EXTERNAL

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC.·Product code HAW·February 16, 2011

    GE OEC 9800

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

    2008T HEMODIALYSIS SYSTEM W/BIBAG

    FDA Adverse Event
    Malfunction ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·June 8, 2016

    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

    PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics.

    FDA Enforcement
    Class II ·Terminated·PTW-Freiburg·September 2, 2015

    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

    Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00. Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the models 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·October 1, 2014

    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