BEUDAMED
    123 results · 34ms · Sources: EU EUDAMED, US FDA

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    BREATHH INC

    FDA registration
    BREATHH INC·2 products·🇺🇸 United States

    IMPELLA

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code OZD·March 12, 2026

    IMPELLA

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code OZD·February 21, 2026

    IMPELLA

    FDA Adverse Event
    Death ·ABIOMED, INC. - 1220648·Product code OZD·February 27, 2026

    PUMP 381 PUMP SET (US)

    FDA Adverse Event
    Injury ·ABIOMED, INC. - 1220648·Product code OZD·March 2, 2026

    UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    M.A.G. INC. ADULT ANESTHESIA BREATHING CIRCUIT

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    MED-PLASTICS INTL., INC. BREATHING FILTER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicated relative Blood Alcohol Concentration (BAC) at 0.02%, 0.04%, 0.05%, 0.06%, 0.08%, or 0.10% cut-off levels.

    FDA Enforcement
    Class III ·Terminated·Acon Laboratories, Inc.·August 5, 2015

    REPLY

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA S.R.L. - CRM FACILITY·Product code DXY·July 17, 2018

    VNS THERAPY PULSE

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·December 8, 2003

    UNIFY QUADRA CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·September 10, 2013

    INGEVITY+

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NVN·January 26, 2021

    ADAPTA DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code NVZ·August 11, 2010

    ADAPTA VDD

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code NVZ·June 11, 2012

    ONQ PUMP

    FDA Adverse Event
    Injury ·UNK·Product code MEB·August 20, 2020

    CONCERTO II CRT-D

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code NIK·February 15, 2011

    PHILIPS DREAM STATION 2 AUTO CPAP ADVANCED

    FDA Adverse Event
    Malfunction ·PHILIPS / RESPIRONICS, INC.·Product code BZD·December 28, 2021

    VNS THERAPY PULSE

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·January 21, 2005

    LIFE2000 VENTILATOR PACKAGED

    FDA Adverse Event
    Injury ·BREATHE TECHNOLOGIES, INC.·Product code CBK·October 30, 2020