BEUDAMED
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    Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180138865·5 MM DIA., 32 CM, NEEDLE HOLDER STRAIGHT CROSS ...

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776208943·NH Str Cross serr TC jaw Inline

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613109400·Laparoscopic Needle Holder, 5mm, Straight Cross...

    Temporary Abutment

    FDA UDI
    BICON, LLC·00813110021960·5.0 x 4.5mm Temporary Abutment - 2.5mm Post

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code OZO·June 5, 2023

    Legend Pro DMA

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307, BP-1326, BP-1318, BP-1319, BP-1211, BP-1312, BSP-11, BSP-12, BSP-13)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    T:SLIM G5 SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code OYC·April 25, 2019

    HOMECHOICE AUTOMATED PD SET W/CASS.-4PRONG, EUR.

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·November 14, 2008

    UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·September 16, 2011

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 26, 2013

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013