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

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    IM-9B MICROINJECTORS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Mariner MIS

    FDA UDI
    Seaspine Orthopedics Corporation·10889981275839·Bevel Stylet, Navigation

    Acid Etching

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746007811·ETCHING SOLUTION LIQUID 14 CC

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 30, 2026

    DIGITAL INTEGRATION SYSTEM, DIS2000

    FDA 510(k)
    FDA Class 2 ·Radiology

    GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 25cc IAB

    FDA UDI
    DATASCOPE CORP.·10607567106632·Insertion Kit with 6” (15cm) Introducer for use...

    Trulink

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522125959·NIBP,HOSE,NEO,QUICK RELEASE TO DH CUFFS

    IMED 960A

    FDA Adverse Event
    Injury ·ALARIS MEDICAL SYSTEMS ATTN: QUALITY CONTROL·Product code FRN·January 3, 1998

    IMED 960A

    FDA Adverse Event
    Injury ·ALARIS MEDICAL SYSTEMS, INC.·Product code FRN·October 1, 1997

    HS III PROXIMAL SEAL

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·February 12, 2013

    SWAN-GANZ CCOMBO CCO/SVO2/VIP THERMODILUTION CATHETER WITH AMC THROMBOSHIELD

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DYG·February 27, 2011

    GORE EXCLUDER BIFURCATED ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES, INC.·Product code MIH·February 21, 2008

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 30, 2026

    smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025

    ALINITY M RESP-4-PLEX AMP KIT

    FDA Adverse Event
    Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·January 31, 2024

    ALINITY M RESP-4-PLEX AMP KIT

    FDA Adverse Event
    Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·January 31, 2024

    ALINITY M RESP-4-PLEX AMP KIT

    FDA Adverse Event
    Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·January 31, 2024

    ALINITY M RESP-4-PLEX AMP KIT

    FDA Adverse Event
    Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·January 31, 2024

    ALINITY M RESP-4-PLEX AMP KIT

    FDA Adverse Event
    Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·January 31, 2024