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    Spectral Medical Inc.

    FDA registration
    Spectral Medical Inc.·2 products·🇨🇦 Canada

    SAMI Hemofiltration Cassette

    FDA UDI
    Spectral Medical Inc·B173SM2000030·The SAMI Hemofiltration Cassette is provided st...

    Endotoxin Activity Assay (EAA)

    FDA UDI
    Spectral Medical Inc·B173EAASTNA0·The EAA™ is a rapid in vitro diagnostic test th...

    Smart Line TL Tube Luminometer

    FDA UDI
    Spectral Medical Inc·B173840070·Smart Line TL Tube Luminometer is a stand-alon...

    Endotoxin Activity Assay (EAA)

    FDA UDI
    Spectral Medical Inc·B173EAAST200·The EAA™ is a rapid in vitro diagnostic test th...

    SAMI RRT

    FDA UDI
    Spectral Medical Inc·B173SM1000030·The SAMI RRT Unit is a software controlled devi...

    SAMI RRT Cassette

    FDA UDI
    Spectral Medical Inc·B173SA400000·The SAMI RRT Cassette is provided sterile, sing...

    Sirius 2 Tube Luminometer

    FDA UDI
    Spectral Medical Inc·B17384018010·The Sirius 2 Tube Luminometer is a highly sensi...

    HEALON 5 PRO

    FDA Adverse Event
    Malfunction ·AMO UPPSALA AB·Product code LZP·May 19, 2022

    TECNIS SIMPLICITY

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code HQL·March 11, 2025

    Auxiliary 2 MHz Continuous Wave (CW) transducer, model number 8251046, when used with ACUSON Sequoia ultrasound systems at SW revision 12.X. Manufactured by Siemens Medical Solutions USA, Inc., Ultrasound Business Unit, Mountain View, CA. The ACUSON Sequoia is a general purpose Diagnostic Ultrasound system. It is intended for the following applications: Abdominal, General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, and penis), Neonatal/Adult Transvaginal, Peripheral Vessels and Musculo-skeletal (superficial and conventional). The system also provides for the measurement of anatomical structures that provide information that is used for clinical diagnosis purposes. The Siemens Aux CW transducer is a non-imaging continuous wave transducer indicated for use in transthoracic/cardiac adult and pediatric applications as well as continuous wave spectral Doppler echocardiography.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code ITX·March 21, 2009