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    FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)

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

    Tiger Supply Inc.

    FDA UDI
    TIGER SUPPLY, INC.·D82360011071·Bite Registration Material Regular Set 2x50ml C...

    DP97

    FDA UDI
    Denplus Inc·D8451001107·DP97, MPD, 454 g

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001107·artVeneer life upper anteriors, BOM, A35

    TruFlex™

    FDA UDI
    Ortho Organizers, Inc.·00190707126544·TRUFLEX NiTi Thermal Euro Upper 16x22 (10pk)

    OCTANE T

    FDA UDI
    Choice Spine, LP·00840996169127·OCTANE T,NON-STRL 7MM

    TruFlex

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730013859·NiTi Thermal Euro Upper 16x22 10 archwires per ...

    Zaffiro IR Treatment Body Applicator

    FDA UDI
    NEAUVIA NORTH AMERICA, INC.·00850017374225·Bigger applicator to perform a non-invasive, th...

    BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610-000, 1107-9612-000, 1107-9616-000, 1107-9617-000, 2066835-001, 2069767-001, 2078800-001, 2091008-001, 2091009-001, M1098876, M1145610, M1220023, M1220854, M1221495, and M1233992

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code CAD·November 18, 2024

    Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610-000, 1107-9612-000, 1107-9616-000, 1107-9617-000, 2066835-001, 2069767-001, 2078800-001, 2091008-001, 2091009-001, M1098876, M1145610, M1220023, M1220854, M1221495, and M1233992

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·January 15, 2025

    Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Datex-Ohmeda Tec 6 Plus and Tec 6 Plus NAD Variant is an electronic vaporizer which delivers the anesthetic agent desflurane. The Tec 6 Plus attaches only to Datex-Ohmeda anesthesia machines equipped with the proprietary Selectatec manifold. The Tec 6 Plus NAD Variant attaches only to NAD anesthesia machines equipped with the NAD exclusion type manifold.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·September 18, 2013

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·February 26, 2013

    RADIAL JAW 4 BIOPSY FORCEPS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA·Product code FCL·February 24, 2011

    LIFEPAK CR PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·February 14, 2008

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·December 1, 2010

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·March 10, 2011

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·June 6, 2011

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·January 5, 2011