BEUDAMED
    31 results · 24ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO AUTOJECT MINI

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Affiniti

    FDA UDI
    TORNIER, INC.·00846832021130·BROACH

    Sledgehammer

    FDA UDI
    Keystone Industries·H66810004821·SC 1 lb Pwd & 8 oz Liq Kit, Lt reddish pink

    CURE™ ACP

    FDA UDI
    MEDITECH SPINE, LLC·B167700004820·

    Ultra Vac

    FDA UDI
    I.C. MEDICAL, INC.·00817688020301·

    TUFF IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·March 12, 2025

    CURE™ ACP

    FDA UDI
    MEDITECH SPINE, LLC·B167S1700004820·

    HARDYDISK TOBRAMYCIN, 10MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST

    FDA 510(k)
    FDA Unclassified ·Unknown

    TUFF IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·March 12, 2025

    HEYER-SCHULTE RADOVAN TISSUE EXPANDER, 400 CC

    FDA Adverse Event
    MENTOR CORP.·Product code LCJ·January 25, 1994

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 20, 2021

    NATURAL Y VOGUE POLYURETHANE SILASTIC IMPLANT, SIZE 11/450GM

    FDA Adverse Event
    MEDICAL ENGINEERING CORP.·Product code FTR·January 25, 1994

    SURGITEK HIGH PROFILE SILASTIC IMPLANT, 600/680 CC

    FDA Adverse Event
    MEDICAL ENGINEERING CORP.·Product code FTR·January 25, 1994

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FPA·March 12, 2013

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code LZG·February 1, 2011

    ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL CO.·Product code HQL·February 21, 2008

    Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482;

    FDA Recall
    Open, Classified ·Abiomed, Inc.·Product code OZD·August 5, 2024

    Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482;

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·September 11, 2024

    Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·January 14, 2026