BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    LumiNE US; Lumi

    FDA 510(k)
    FDA Class 2 ·Radiology

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776181901·BRUNS CURETTE ANG OVAL SIZE

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257009833·30-40 DUAL LAYER CALF SINGLE L 10 PACK

    COE TRAY PLASTIC™

    FDA UDI
    Gc America Inc.·D6582400941·COE TRAY PLASTIC™ Liquid, 1 gallon (4 1-qt. cans)

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780187288·Integra® Jarit® Bruns Oval Cup Curette, 8", Ang...

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180178779·Micro Blunt Hook 8" Overall Length, 3" Knurled ...

    PIGGYBACK IRRIGATING SYSTEM

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

    SPRINGTMS TOTAL MIGRAINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    I-STAT EG7+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·April 9, 2024

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 10, 2014

    PELVISOFT ACELLULAR COLLAGEN BIOMESH

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABORATORIES·Product code FTM·July 18, 2013

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·April 23, 2024

    ACCOLADE DR SL MRI (Model L311)

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