BEUDAMED
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    SAM JUNCTIONAL TOURNIQUET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ArgenIS

    FDA UDI
    ARGEN CORPORATION, THE·D818131561·TiBase BLX RB/WB 1.5G NE

    TX1 TISSUE REMOVAL SYSTEM

    FDA 510(k)
    FDA Unclassified ·Unknown

    CARDIOSOFT/CASE CARDIAC TESTING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 28, 2025

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·October 1, 2014

    EZ BREATHE ATOMIZER

    FDA Adverse Event
    HEALTH & LIFE (SUZHOU) CO., LTD.·Product code CCQ·May 17, 2013

    CARELINK PROGRAM W/TELEMETRY C

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DXY·June 16, 2011

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·July 16, 2020

    TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections. Indiciated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.

    FDA Enforcement
    Class II ·Terminated·American Optisurgical Inc·June 27, 2012