BEUDAMED
    131 results · 64ms · Sources: EU EUDAMED, US FDA

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    HYDROFLOSS WATER FLOSSER

    FDA Adverse Event
    Malfunction ·ORAL CARE TECHNOLOGIES, INC.·Product code EFS·May 18, 2023

    GONGQINGCHENG MULTI TECHNOLOGY HEALTH CARE INC.

    FDA registration
    GONGQINGCHENG MULTI TECHNOLOGY HEALTH CARE INC.·1 product·🇨🇳 China

    HEMOLUNG RAS

    FDA Adverse Event
    Injury ·ALUNG TECHNOLOGIES, INC.·Product code DQR·January 16, 2023

    CINEMAVISION A/V SYSTEM

    FDA Adverse Event
    Injury ·RESONANCE TECHNOLOGY, INC.·Product code LNH·July 20, 2012

    HEMOLUNG RAS

    FDA Adverse Event
    Injury ·ALUNG TECHNOLOGIES, INC.·Product code QOH·January 18, 2023

    HEMOLUNG RAS

    FDA Adverse Event
    Injury ·ALUNG TECHNOLOGIES, INC.·Product code QOH·January 18, 2023

    HEMOLUNG RAS

    FDA Adverse Event
    Death ·ALUNG TECHNOLOGIES, INC.·Product code QOH·January 18, 2023

    Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies. This product is used to alert caregivers when a patient at risk for falls is leaving a bed or chair.

    FDA Enforcement
    Class II ·Terminated·RF Technologies, Inc.·July 3, 2013

    One Touch Basic/Profile and One Touch Ultra Blood Glucose Test Strips

    FDA Recall
    Terminated ·Core Care Technologies, Inc·Product code NBW·October 14, 2006

    HEMOLUNG RAS

    FDA Adverse Event
    Injury ·ALUNG TECHNOLOGIES, INC.·Product code DQR·January 17, 2023

    HALLU FIX

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL CO·Product code HWC·August 14, 2003

    INTELISWAB COVID-19 RAPID TEST

    FDA Adverse Event
    Malfunction ·ORASURE TECHNOLOGIES INC.·Product code QKP·January 7, 2022

    i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac troponin I measurements can be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality. The cartridge is to be used with the i-Stat Analyzer, but not with the i-Stat Portable Clinical Analyzer or the Philips Medical System (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-Stat System, the cTnl test is to be used by trained health care professionals in accordance with a facility's policies and procedures.

    FDA Enforcement
    Class II ·Terminated·Abbott Point Of Care Inc.·August 15, 2012

    SMARTLOAD

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code HQL·June 23, 2021

    BALLOON MINI ONE BUTTON

    FDA Adverse Event
    Other ·APPLIED MEDICAL TECHNOLOGY, INC.·Product code KNT·February 13, 2013

    INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE

    FDA Adverse Event
    Injury ·VERTEBRAL TECHNOLOGIES, INC.·Product code MAX·March 16, 2011

    WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY

    FDA Adverse Event
    Death ·BIOSENSE WEBSTER INC.·Product code DRF·June 5, 2019

    EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·April 12, 2019

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·April 12, 2019

    INTELISWAB COVID-19 RAPID TEST

    FDA Adverse Event
    Malfunction ·ORASURE TECHNOLOGIES, INC.·Product code QKP·November 27, 2024