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    DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ELMED

    FDA UDI
    ELMED INCORPORATED·00198506060663·ELMED REUSABLE MONOPLAR ELECTRODES - LOOP ELE...

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180134959·ELMED REUSABLE MONOPOLAR ELECTRODES - LOOP ELEC...

    Bright Tray

    FDA UDI
    ORMCO CORPORATION·00889989059748·BRIGHT TRAY-UPPER-SIZE 14-BLUE-PK 20

    HEMOSTAT KOCHER 5 1/2" CURVED

    FDA UDI
    W.H. Holden, Inc.·D9281400430·

    Spacelabs Healthcare

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522125966·NIBP,DUAL HOSE,CRITIKON MONITOR TO DH CUFFS

    Coaxial needle

    FDA UDI
    Möller Medical GmbH·04260277171964·

    NDX-40 ALLOY

    FDA 510(k)
    FDA Class 2 ·Dental

    COROENT XLR STANDALONE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HISTOACRYL FLEXIBLE PACK 5

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·December 3, 2019

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·August 26, 2019

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·February 6, 2019

    ELITE, ROLL AROUND INJ SYSTEM

    FDA Adverse Event
    Malfunction ·LIEBEL - FLARSHEIM CO.·Product code DXT·May 29, 2013

    COLLEAGUE PRE-P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 25, 2011

    EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code KRH·August 26, 2008

    HISTOACRYL FLEXIBLE PACK 5

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL SA·Product code MPN·February 11, 2020

    HISTOACRYL TRANSLUCENT 10 AMP OF 0.5 ML

    FDA Adverse Event
    Injury ·B. BRAUN SURGICAL SA·Product code MPN·February 26, 2020

    EQUINOXE SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWS·January 9, 2024

    C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·December 11, 2013

    Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013