BEUDAMED
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    ZQUIET-SA

    FDA 510(k)
    FDA Class 2 ·Dental

    LCP RADIAL HEAD PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ABL837 FLEX ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD SYRINGE¿ 5ML SALINE FILL

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·January 7, 2020

    SYRINGE 5ML SALINE FILL

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·February 28, 2020

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 3, 2014

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    DAIGLER KUNSTSTOFFSPRITZEREI GMBH·Product code IKX·May 31, 2013

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code INK·June 15, 2011

    SYRINGE 5ML SALINE FILL CHINA SP

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·June 3, 2020

    ARTOURA BREAST TISSUE EXPANDER

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·August 21, 2023

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    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

    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

    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