BEUDAMED
    31 results · 57ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    AXIOM DIAGNOSTICS, INC.

    FDA registration
    AXIOM DIAGNOSTICS, INC.·3 products·🇺🇸 United States

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code MIH·July 16, 2018

    Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Model Numbers: System Material # AXIOM Artis FC 05904433; AXIOM Artis FA 05904441; AXIOM Artis MP 05904466; AXIOM Artis BC 05904649; AXIOM Artis BA 05904656; AXIOM Artis dBC Mag. Nav. 05917054; AXIOM Artis TA 07007755; AXIOM Artis dTA 07008605; AXIOM Artis dFC 07412807; AXIOM Artis dTC 07413078; AXIOM Artis dBA 07555357; AXIOM Artis dMP 07555365; AXIOM Artis dFA 07555373; AXIOM Artis dFC Mag. Nav. 07727717; AXIOM Artis TC 07728350; AXIOM Artis dBC 07728392; Artis zee floor 10094135; Artis zee ceiling 10094137; Artis zee MP 10094139; Artis zee biplane 10094141; Artis zee floor MN 10094142; Artis zee biplane MN 10094143; Artis Q floor 10848280; Artis Q ceiling 10848281; Artis Q biplane 10848282; Artis Q.zen floor 10848353; Artis Q.zen ceiling 10848354; Artis Q.zen biplane 10848355.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·March 30, 2021

    IMPELLA

    FDA Adverse Event
    Death ·ABIOMED, INC. - 1220648·Product code OZD·February 21, 2026

    PC GEN 2, NON-QSK, STERILE, JAPAN

    FDA Adverse Event
    Death ·ABIOMED, INC. - 1220648·Product code OZD·February 24, 2026

    IMPELLA

    FDA Adverse Event
    Malfunction ·ABIOMED, INC.·Product code OZD·April 29, 2026

    IMPELLA

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code OZD·May 17, 2026

    IMPELLA

    FDA Adverse Event
    Malfunction ·ABIOMED, INC. - 1220648·Product code OZD·May 21, 2026

    IMPELLA

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code OZD·March 9, 2026

    IMPELLA

    FDA Adverse Event
    Malfunction ·ABIOMED, INC. - 1220648·Product code OZD·May 21, 2026

    IMPELLA

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code OZD·February 27, 2026

    IMPELLA

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code OZD·May 27, 2026

    IMPELLA

    FDA Adverse Event
    Death ·ABIOMED, INC. - 1220648·Product code OZD·May 15, 2026

    IMPELLA

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code OZD·May 15, 2026

    IMPELLA

    FDA Adverse Event
    Injury ·ABIOMED, INC.·Product code OZD·April 28, 2026

    IMPELLA

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code PYX·March 5, 2026

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code OZD·March 17, 2026

    PUMP 371 14F LT CMR SET

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code OZD·February 18, 2026

    KIT, 14FR INTRODUCER, 13CM&25CM, STERILE

    FDA Adverse Event
    Malfunction ·ABIOMED, INC. - 1220648·Product code DYB·March 9, 2026

    RP FLEX W SMART ASSIST SET, US

    FDA Adverse Event
    Death ·ABIOMED, INC.·Product code PYX·February 16, 2026