BEUDAMED
    1,428 results · 38ms · Sources: EU EUDAMED, US FDA

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    PKS OMNI

    FDA Adverse Event
    Malfunction ·GYRUS AMCI. INC.·Product code GEI·March 28, 2013

    PK DIEGO 2MM STR AGG TURBINATE

    FDA Adverse Event
    Other ·GYRUS AMCI, INC.·Product code ERL·January 15, 2013

    BCI INTERNATIONAL

    FDA Adverse Event
    Injury ·BCI INTERNATIONAL, INC.·Product code DQA·June 3, 1999

    BCI INTERNATIONAL

    FDA Adverse Event
    Injury ·BCI INTERNATIONAL, INC.·Product code DQA·June 3, 1999

    BCI INTERNATIONAL

    FDA Adverse Event
    Injury ·BCI INTERNATIONAL, INC.·Product code DQA·June 3, 1999

    PULSE OXIMETER

    FDA Adverse Event
    Injury ·BCI INTL., INC.·Product code DQA·February 3, 1995

    ROTATING CONTINUOUS FLOW RESECTOSCOPE SHEATH

    FDA Adverse Event
    Malfunction ·GYRUS AMCI INC·Product code FJL·August 21, 2014

    SIM BCI OXYGEN SATURATION MONITOR

    FDA Adverse Event
    Malfunction ·SIMS BCI, INC·Product code DQA·February 1, 2001

    PKS PLASMASORD (5/PK)

    FDA Adverse Event
    Injury ·GYRUS AMCI, INC.·Product code GEI·May 17, 2016

    USA ELITE SYSTEM RIGID OPTICAL TEARING BIOPSY

    FDA Adverse Event
    Malfunction ·GYRUS AMCI, INC.·Product code KNW·March 30, 2015

    ROTATING OF RESECTOSCOPE INNER SHEATH

    FDA Adverse Event
    Malfunction ·GRUS AMCI INC.·Product code FJL·March 27, 2015

    FBK DUAL INC. W/O TROCAR 8/PK

    FDA Adverse Event
    Injury ·GYRUS AMCI, INC.·Product code KNH·April 26, 2016

    PK BUTTON (BOX OF 5)

    FDA Adverse Event
    Malfunction ·GYRUS AMCI, INC.·Product code FAS·May 27, 2016

    PKS PLASMASORD (5/PK)

    FDA Adverse Event
    Death ·GYRUS AMCI, INC.·Product code GEI·May 17, 2016

    BCI PULSE PATIENT CABLE

    FDA Adverse Event
    Death ·SIMS BCI, INC·Product code DSA·December 4, 2002

    KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 (OUS) Labeling: The KAMRA inlay is indicated for the improvement of near visual acuity in one eye (usually the non-dominant eye) of a presbyopic patient.

    FDA Enforcement
    Class II ·Terminated·AcuFocus, Inc.·March 30, 2016

    ACIS IMPLANT INSERTER

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code LXH·May 29, 2013

    UNK - CONSTRUCTS: ACIS

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HRS·October 11, 2021

    UNK - CONSTRUCTS: ACIS

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code MNH·October 11, 2021

    ACIS IMPLANT HOLDER

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code LXH·February 21, 2024