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    HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    Hitachi HIVISION Preirus/Avius Ultrasound equipped with V03.02 Software - Doppler Trace Measurement program. 510 (k) Numbers: Preirus - K093466 (6/1/10), Avius - K102901 (10/27/10). The Preirus and Avius are intended for use by trained personnel (doctors, sonographers, etc) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Feta, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Genecology, Urology and Laparoscopic clinic applications. The Modes of Operation of the HIVISION Preirus are B mode, M mode PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler) Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, RealTime Tissue Elastography, and Real Time Virtual Sonography.

    FDA Recall
    Terminated ·Hitachi Medical Systems America Inc·Product code IYN·April 18, 2011

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814640·GENUMEDI SILVER SIZE I

    ILIZAROV SYSTEMS

    FDA UDI
    MEDICALPLASTIC SRL·08033201842034·WRENCH FOR GRADUATED TELESCOPIC ...

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00850038691011·

    Tasso Mini

    FDA UDI
    Tasso Inc.·00850038691134·

    COLOR-MONOGEN

    FDA 510(k)
    FDA Class 2 ·Immunology

    KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM (US)

    FDA Adverse Event
    Injury ·SALUDA MEDICAL PTY LTD·Product code LGW·June 12, 2025

    EVOKE CAP12 PERCUTANEOUS LEAD KIT - 90CM (US)

    FDA Adverse Event
    Injury ·SALUDA MEDICAL PTY LTD·Product code LGW·January 14, 2026

    EVOKE CLOSED LOOP STIMULATOR (CLS) (US)

    FDA Adverse Event
    Injury ·SALUDA MEDICAL PTY LTD·Product code LGW·April 3, 2026

    ACTIVE ANCHOR KIT L (US)

    FDA Adverse Event
    Injury ·SALUDA MEDICAL PTY LTD·Product code LGW·August 28, 2025

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 9, 2013

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·September 19, 2014

    MAVERICK BALLOON DILATION CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code LOX·May 25, 2011

    EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM (US)

    FDA Adverse Event
    Injury ·SALUDA MEDICAL PTY LTD·Product code LGW·June 12, 2025

    DIRECT CLAMP ACTIVE ANCHOR KIT

    FDA Adverse Event
    Injury ·SALUDA MEDICAL PTY LTD·Product code LGW·February 20, 2026

    EVOKE CLOSED LOOP STIMULATOR (CLS) (US)

    FDA Adverse Event
    Injury ·SALUDA MEDICAL PTY LTD·Product code LGW·April 1, 2026

    MINIMED QUICK-SET

    FDA Adverse Event
    Injury ·UNOMEDICAL UM-D·Product code FPA·January 28, 2025

    RICKHAM RESERVOIR

    FDA Adverse Event
    Injury ·JOHNSON AND JOHNSON PROFESSIONAL, INC. / MEDOS S.A·Product code JXG·November 20, 2015