BEUDAMED
    11 results · 25ms · Sources: EU EUDAMED, US FDA

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    BRUCELLA AGAR W/15% SHEEP BLOOD

    FDA 510(k)
    FDA Class 1 ·Microbiology

    OVATION®

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K82055261·OVATION® Base Rx SP 022 UL/5-5 CS-BC DHK

    OVATION®

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K82055241·OVATION® Base Rx 022 UL/5-5 CS-BC MHK

    OVATION®

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K82055221·OVATION® Base Rx 022 UL/5-5 CS-BC DHK

    TRIGLYCERIDES TEST (500NM)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SIMUPLAN TREATMENT PLANNING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SUR-FIT NATURA 2 PC UROSTOMY POUCH W/ACCUSEAL

    FDA Adverse Event
    Malfunction ·CONVATEC INC.·Product code EXH·April 11, 2014

    GORE TAG THORACIC ENDOPROTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·October 25, 2012

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·August 31, 2010

    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

    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 29, 2012