BEUDAMED
    253 results · 50ms · 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.

    CATHETER INTRODUCER KIT PCI KIT/5 REF/REORDER NO. 496185. Disposable Single Use, Rx.. Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DRE·March 29, 2010

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM

    FDA Adverse Event
    Injury ·SHOCKWAVE MEDICAL, INC.·Product code QMG·June 23, 2023

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM

    FDA Adverse Event
    Injury ·SHOCKWAVE MEDICAL, INC.·Product code QMG·March 18, 2024

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    FDA Adverse Event
    Death ·SHOCKWAVE MEDICAL, INC.·Product code QMG·August 12, 2022

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM

    FDA Adverse Event
    Injury ·SHOCKWAVE MEDICAL, INC.·Product code QMG·May 12, 2023

    IMPELLA

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code OZD·May 14, 2026

    IMPELLA

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code OZD·April 6, 2026

    IMPELLA CP

    FDA Adverse Event
    Injury ·ABIOMED, INC.·Product code OZD·January 4, 2026

    INTRODUCER, CATHETER (INTRODUCER)

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code DYB·April 2, 2026

    TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

    FDA Adverse Event
    Malfunction ·ABIOMED, INC. - 1220648·Product code OZD·April 8, 2026

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM

    FDA Adverse Event
    Death ·SHOCKWAVE MEDICAL, INC.·Product code QMG·August 28, 2023

    INTRODUCER, CATHETER (INTRODUCER)

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code DYB·April 8, 2026

    IMPELLA

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code OZD·May 22, 2026

    SHEATH, 7FR SINGLE ACCESS SHEATH

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code DYB·April 2, 2026

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·November 4, 2022

    IMPELLA

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code OZD·April 8, 2026

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

    FDA Adverse Event
    Malfunction ·ABIOMED, INC. - 1220648·Product code DYB·March 26, 2026

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

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code DYB·March 13, 2026

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM

    FDA Adverse Event
    Injury ·SHOCKWAVE MEDICAL, INC.·Product code QMG·July 20, 2023

    SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM

    FDA Adverse Event
    Injury ·SHOCKWAVE MEDICAL, INC.·Product code QMG·May 1, 2023