BEUDAMED
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    UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925017702·APPLEBAUM INCUS REPLACEMENT 2.5MM DENSE HYDROXY...

    SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·January 28, 2021

    CALCIUM, AZO DYE REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    UNKNOWN NEXGEN FLUTED STEM TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code JWH·May 24, 2013

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 27, 2011

    MYNX VASCULAR CLOSURE DEVICE

    FDA Adverse Event
    Injury ·ACCESSCLOSURE, INC.·Product code MGB·August 27, 2008

    ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

    FDA Adverse Event
    Injury ·COOK INC·Product code MIH·August 24, 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