BEUDAMED
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    NEUROLAC(R) NERVE GUIDE

    FDA 510(k)
    FDA Class 2 ·Neurology

    n/a

    FDA UDI
    HANS RUDOLPH, INC.·00874750006229·2700MPL 2WAY NRBV W/MPC SALIVA

    CONCISE, SILICONE HYDROGEL DAILY WEAR SOFT CONTACT LENS (EFROFILCON A)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ELECSYS FERRITIN CALCHECK 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 12, 2024

    BIOMEDICS 1 DAY (52%) STRIP (OCUFILCON B)

    FDA Adverse Event
    Injury ·COOPERVISION CARRIBEAN CORPORATION·Product code MVN·August 29, 2019

    HOT SHEARS (TM) (MONOPOLAR CURVED SCISSORS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·May 14, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 23, 2014

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·May 24, 2011

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·April 18, 2022

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 24, 2024

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code PSZ·January 22, 2024

    KIT FLU VERITOR SYSTEM 30 TEST JAPAN

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 1, 2022

    KIT FLU VERITOR SYSTEM 30 TEST JAPAN

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 19, 2021

    KIT FLU VERITOR SYSTEM 30 TEST JAPAN

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 25, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021