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

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    WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    35/CD CINECONVERTER

    FDA 510(k)
    FDA Class 2 ·Radiology

    XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·January 16, 2019

    UNKNOWN COPELAND SHOULDER

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code HSD·April 14, 2017

    COPELAND SH HUM SZ4 STND PLUS

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code HSD·June 8, 2016

    UNKNOWN COPELAND HEMIARTHROPLASTY SHOULDER

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code HSD·October 21, 2016

    UNKNOWN COPELAND RESURFACING SHOULDER

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code HSD·May 16, 2017

    UNKNOWN COPELAND SHOULDER GLENOID COMPONENT

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code HSD·July 5, 2017

    COMPRESSION FORCEPS

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code HTD·April 10, 2013

    PULSE GEN MODEL 102

    FDA Adverse Event
    Death ·CYBERONICS, INC.·Product code LYJ·September 2, 2014

    5MM, 33CM PEEK MONOPOLAR HANDLE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code GEI·March 15, 2011

    CustomEyes kits

    FDA Enforcement
    Class II ·Ongoing·Beaver Visitec International, Inc.·March 8, 2023

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MAF·November 13, 2018

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018