BEUDAMED
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    Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000)

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257125809·30-40 MV FOR MEN CLSC CALF STD TAN V

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690117391·Modular Knee Stem Pilot 13mm x 150mm

    AVANOS

    FDA UDI
    Avanos Medical, Inc.·00609038200866·BALLARD* Seal Cassette Replacement for Closed S...

    SacroFuse

    FDA UDI
    SPINEFRONTIER, INC.·00190361023388·Ø10MM SLOTTED FUSION SCREW, GEN II, SACROFUSE, ...

    THERMAGE THERMACOOL SYSTEM

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

    RGK Daily Range Wheelchairs

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·November 4, 2014

    INGENIO

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 22, 2013

    BIO-COMP. INTERFERENCE SCREW

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code MAI·October 14, 2016

    BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; Sterile; Single Use

    FDA Enforcement
    Class II ·Terminated·Avanos Medical, Inc.·April 6, 2022

    MultiDiagnostic-Eleva with Flat Detector 708038 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Nederlands·May 9, 2018

    Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Nederlands·May 9, 2018

    MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020

    a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS55

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025