BEUDAMED
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    ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VIADUCT MINISCOPE AND ACCESSORIES

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

    BICERA (TM) RESORBABLE BONE SUBSTITUTE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·June 3, 2013

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (SMALL)

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LTI·June 21, 2011

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 3, 2008

    OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 4/3 X 13MM

    FDA Adverse Event
    Injury ·BIOMET 3I·Product code DZE·September 29, 2025

    SEE H10

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·September 23, 2020

    SEE H10

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·September 23, 2020

    SEE H10

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·September 23, 2020

    C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·September 24, 2014

    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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018