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    ELISIO-H HEMODIALYZER

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

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925015692·HOUSE-TYPE SS WIRE LP

    BICONTACT HIP STEM AND FEMORAL HEAD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONFIRM

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code MXC·January 13, 2014

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 29, 2013

    SYNCHRON LX RHEUMATOID FACTOR (RF) REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code DHR·June 25, 2011

    ISODUR PROSTHESIS HEAD 12/14 28MM M

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code LPH·January 16, 2015

    UNKNOWN GAMMA 3 NAIL

    FDA Adverse Event
    Injury ·STRYKER TRAUMA KIEL·Product code HSB·June 26, 2022

    UNKNOWN GAMMA 3 NAIL

    FDA Adverse Event
    Injury ·STRYKER TRAUMA KIEL·Product code HSB·June 27, 2022

    UNKNOWN GAMMA 3 NAIL

    FDA Adverse Event
    Injury ·STRYKER TRAUMA KIEL·Product code HSB·June 26, 2022

    UNKNOWN GAMMA 3 NAIL

    FDA Adverse Event
    Injury ·STRYKER TRAUMA KIEL·Product code HSB·June 26, 2022

    UNKNOWN GAMMA 3 NAIL

    FDA Adverse Event
    Injury ·STRYKER TRAUMA KIEL·Product code HSB·June 26, 2022

    UNKNOWN GAMMA 3 NAIL

    FDA Adverse Event
    Injury ·STRYKER TRAUMA KIEL·Product code HSB·June 26, 2022

    UNKNOWN GAMMA 3 NAIL

    FDA Adverse Event
    Injury ·STRYKER TRAUMA KIEL·Product code HSB·June 27, 2022

    UNKNOWN GAMMA 3 NAIL

    FDA Adverse Event
    Injury ·STRYKER TRAUMA KIEL·Product code HSB·June 26, 2022

    BD MAX¿ ENTERIC BACTERIAL PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCI·October 12, 2023

    UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Product Usage: Note: The DxH 600 hematology analyzer is the same instrument as the DxH 800 (K140911), except that it is a benchtop unit with no instrument cart, computer stand, and no connectivity capabilities. DxH 800 intended use states: The UniCel DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel¿ DxH 800 Analyzer identifies and enumerates the parameters indicated below on the following sample types: Whole Blood (Venous and Capillary) o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO#, BA%, BA#, NRBC%, NRBC#, RET%, RET#, MRV, IRF Pre-Diluted Whole Blood (Venous and Capillary) o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV Body Fluids (cerebrospinal, serous and synovial) o TNC and RBC

    FDA Enforcement
    Class I ·Terminated·Beckman Coulter Inc.·May 29, 2019

    UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478 Product Usage: Note: The DxH 900 hematology analyzer is CLIA categorized under document CR180294 and is currently marketed as a member of the instrument family of the DxH 800 cleared under K140911, per FDA s guidance, Guidance for Industry and FDA Staff, Replacement Reagent and Instrument Family Policy . DxH 800 intended use states: The UniCel DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel¿ DxH 800 Analyzer identifies and enumerates the parameters indicated below on the following sample types: Whole Blood (Venous and Capillary) o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO#, BA%, BA#, NRBC%, NRBC#, RET%, RET#, MRV, IRF Pre-Diluted Whole Blood (Venous and Capillary) o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV Body Fluids (cerebrospinal, serous and synovial) o TNC and RBC

    FDA Enforcement
    Class I ·Terminated·Beckman Coulter Inc.·May 29, 2019

    Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Number 58403-000). Intended for patients for whom the monitoring of continuous cardiac output is indicated for diagnostic and prognostic evaluation by a clinician in the hospital.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·May 16, 2018