BEUDAMED
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    GSB LLC

    FDA registration
    GSB LLC·1 product·🇺🇸 United States

    Microtable System

    FDA UDI
    Gsb LLC·00196852534531·The Microtable System is a patient-specific sur...

    enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantitative measurement of a variety of analytes of clinical interest --- Background: The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·June 11, 2014

    enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantitative measurement of a variety of analytes of clinical interest --- Background: The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·March 20, 2014

    GSM, LLC

    FDA registration
    GSM, LLC·1 product·🇺🇸 United States

    GCB MEDICAL LLC

    FDA registration
    GCB MEDICAL LLC·10 products·🇺🇸 United States

    ESB GRANDE

    FDA Adverse Event
    Other ·ESB ENTERPRISES, LLC·Product code LEJ·March 4, 2005

    23G SAFETY PUSH BUTTON BLOOD COLLECTION KITS BUTTERFLY NEEDLES

    FDA Adverse Event
    Malfunction ·GCB MEDICAL LLC·Product code JKA·January 26, 2026

    21G SAFETY PUSH BUTTON BLOOD COLLECTION KITS BUTTERFLY NEEDLES

    FDA Adverse Event
    Malfunction ·GCB MEDICAL LLC·Product code JKA·January 26, 2026

    GCB Medical Supply

    FDA UDI
    GCB MEDICAL LLC·00850061859693·GCB MEDICAL UNDERPAD 30 X 36" HEAVY ABSORBENT

    GCB Medical Supply

    FDA UDI
    GCB MEDICAL LLC·00810184642329·GCB MEDICAL PANTS SCRUB DISPOSABLE MEDIUM ELAST...

    GCB Medical Supply

    FDA UDI
    GCB MEDICAL LLC·00810184642695·GCB MEDICAL SAFETY BLOOD COLLECTIONNEEDLE WITHO...

    GCB Medical Supply

    FDA UDI
    GCB MEDICAL LLC·00810184642428·GCB MEDICAL TOP SCRUB DISPOSABLE 3XLARGE V-NECK...

    GCB Medical Supply

    FDA UDI
    GCB MEDICAL LLC·00810184641209·GCB MEDICAL COVERALL XL OPEN CUFF COLLAR SMS WHITE

    GCB Medical Supply

    FDA UDI
    GCB MEDICAL LLC·00810184641261·GCB MEDICAL AAMI 2 SMS GOWN OTH SIDE TIES THUMB...

    GCB Medical Supply

    FDA UDI
    GCB MEDICAL LLC·00810184642701·GCB MEDICAL SAFETY BLOOD COLLECTIONNEEDLE WITHO...

    GCB Medical Supply

    FDA UDI
    GCB MEDICAL LLC·00810184642152·GCB MEDICAL SAFETY PUSH BUTTON BLOOD COLLECTION...

    GCB Medical Supply

    FDA UDI
    GCB MEDICAL LLC·00810184641193·GCB MEDICAL LAB JACKET BLUE XXL

    GCB Medical Supply

    FDA UDI
    GCB MEDICAL LLC·00850061859204·GCB MEDICAL SURGEON CAP PREMIUM

    GCB Medical Supply

    FDA UDI
    GCB MEDICAL LLC·00810184641230·GCB MEDICAL COVERALL XXL ELASTIC CUFF COLLAR SM...