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    FIRST SOURCE INC.

    FDA registration
    FIRST SOURCE INC.·4 products·🇺🇸 United States

    iQ Elevation

    FDA UDI
    First Source, Inc.·G221100DRWBS0·A weight bearing stand that will allow a patien...

    iQ Flex

    FDA UDI
    First Source, Inc.·G221500MC0740·Mobile X-ray System consisting of a LED display...

    iQ Flex

    FDA UDI
    First Source, Inc.·G221500MC0800·This Mobile X-ray System (Model: iQFlex M/iQFle...

    iQ View

    FDA UDI
    First Source, Inc.·G221200CA3080·The I-Q View is a software package to be used w...

    iQ Panorama

    FDA UDI
    First Source, Inc.·G221100DRSTS0·A weight bearing stand that will allow a patien...

    IQ FLEX M

    FDA Adverse Event
    Malfunction ·FIRST SOURCE INC.·Product code IZL·May 29, 2024

    First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.

    FDA Recall
    Open, Classified ·First Source Inc·Product code IZL·May 9, 2024

    First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.

    FDA Recall
    Open, Classified ·First Source Inc·Product code IZL·May 9, 2024

    First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.

    FDA Enforcement
    Class II ·Ongoing·First Source Inc·July 10, 2024

    First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.

    FDA Enforcement
    Class II ·Ongoing·First Source Inc·July 10, 2024

    MCGRATH

    FDA Adverse Event
    Injury ·AIRCRAFT MEDICAL LIMITED·Product code CAL·November 13, 2018

    COMPANION 5

    FDA Adverse Event
    Death ·CAIRE INC.·Product code CAW·May 9, 2024

    Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007, 5) BT-20-0011, and 6) RMS010118CP

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code CBK·September 12, 2024

    LIBERATOR

    FDA Adverse Event
    Death ·Product code BYJ·December 31, 2020

    NIR HANDHELD CAMERA

    FDA Adverse Event
    Malfunction ·SCHOELLY FIBEROPTIC GMBH·Product code GCJ·March 18, 2026

    SUREFORM

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code GDW·December 29, 2023

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·April 17, 2026

    Eclipse Radiation Treatment Planning System, model H48; Varian Medical Systems Inc..

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code MUJ·May 3, 2011

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·August 31, 2023