BEUDAMED
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    SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

    FDA Recall
    Terminated ·Steris Corporation Hopkins Facility·Product code MED·December 7, 2011

    Bur PM2-95 80K MstickD Ø4.0St

    FDA UDI
    Bien-Air Surgery SA·17630055519990·

    The Orthodontic Store

    FDA UDI
    Young Innovations, Inc.·00843471156117·V D-Form 020

    Stainless Steel Archwires

    FDA UDI
    Ortho Organizers, Inc.·00190707065492·.020 Lower Bright Stainless Steel Oval Arch For...

    Admiral

    FDA UDI
    Seaspine Orthopedics Corporation·10889981277222·Modular Trial, 14 x 13 x 9mm, 7 Deg Lordosis

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383556071·Gutta Percha Points is used to root canal filin...

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383500852·Gutta Percha Points is used to root canal filin...

    eTRAX™ Needle

    FDA UDI
    CIVCO MEDICAL INSTRUMENTS CO., INC.·00841436103237·Sterile needle, 14GA x 9cm with (7.6 tapered to...

    eTRAX™ Needle

    FDA UDI
    CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436103241·Sterile needle, 14GA x 9cm with (7.6 tapered to...

    WAVEWRITER ALPHA PRIME 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 7, 2023

    SLT LASERPRO CTH HOLMIUM LASER SYSTEM

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

    GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Ascendant

    FDA UDI
    Choice Spine, LP·10885862260505·

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·July 2, 2019

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 29, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 3, 2014

    MINICAP TRANSFER SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 24, 2011

    PANTHER FUSION ADV/HMPV/RV ASSAY

    FDA Adverse Event
    Injury ·HOLOGIC INCORPORATED·Product code OCC·October 12, 2021

    PANTHER FUSION SARS-COV-2 ASSAY PPR SOLUTION

    FDA Adverse Event
    Malfunction ·HOLOGIC INCORPORATED·Product code QJR·October 11, 2021