BEUDAMED
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    Tumark for Eviva, Tumark for Brevera

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515026629·Hibbs Ret, #2 only, 1x 3 1/4", 9 1/2"

    GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470

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

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 14, 2025

    IMP,TSV,4.1MM,DUAL SEL,HA

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·February 5, 2024

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·February 5, 2024

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, NEUROMODULATION·Product code LGW·June 14, 2013

    N/A

    FDA Adverse Event
    Malfunction ·NEURO - VILLALBA·Product code LGW·October 17, 2014

    ADVANTAGE SERIES 29

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·June 22, 2011

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 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