BEUDAMED
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    PAR 5 ACETABULAR COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Affiniti

    FDA UDI
    TORNIER, INC.·00846832024650·HUMERAL HEAD TRIAL

    CUSTOM PROCEDURE KIT

    FDA UDI
    MEDIVATORS INC.·40677964003507·The ENDO CARRY-ON Procedure Kit contains all of...

    Tobii Dynavox

    FDA UDI
    TOBII DYNAVOX LLC·07340074601998·Speech Generating Device with Eye tracking capa...

    SR Facebow

    FDA UDI
    ORMCO CORPORATION·00889989023398·Facebow MINI-VEC SZ 4 .050 DIA

    FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN

    FDA 510(k)
    FDA Unclassified ·Unknown

    ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1

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

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 4, 2025

    TUFF IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·August 18, 2025

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·March 12, 2013

    MX-PRO R-3 AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code INK·February 18, 2011

    BLADE MERLIN, CUDA, 15 DEGREES CURVED 4.2MM

    FDA Adverse Event
    Malfunction ·CONMED LINVATEC·Product code GFA·February 14, 2008

    OXFORD MP SLOT POST CUT GD SML

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LXH·December 9, 2025

    OXF MP SLOT POST CUT GD LGE RG

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code HWA·March 21, 2020

    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

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    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