BEUDAMED
    45 results · 103ms · Sources: EU EUDAMED, US FDA

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    SAFESEPT

    FDA Adverse Event
    Malfunction ·PRESSURE-PRODUCTS MEDICAL SUPPLIES, INC.·Product code DYB·September 3, 2013

    PRESSURE PRODUCTS

    FDA Adverse Event
    Malfunction ·PRESSURE PRODUCTS MEDICAL SUPPLIES, INC.·Product code DYB·June 9, 2015

    SHIFENG

    FDA Adverse Event
    Malfunction ·CHENGDU XINJIN SHIFENG MEDICAL·Product code FMI·November 11, 2022

    DROPSAFE

    FDA Adverse Event
    Malfunction ·HTL STREFA S A·Product code FMI·November 11, 2022

    MAXTEC MICROMAX

    FDA Adverse Event
    Malfunction ·PRECISION MEDICAL INC·Product code BZR·December 20, 2019

    LEVEL 1 FAST FLOW FLUID WARMER

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC·Product code BSB·April 3, 2025

    RESPLABS CPAP HOSE PERFECT FIT REPLACEMENT TUBING FOR ALL CPAP MACHINES 6FT STAN

    FDA Adverse Event
    Injury ·RESPLABS MEDICAL USA INC.·Product code BYX·June 20, 2024

    UMBLICAL CORD CLAMP

    FDA Adverse Event
    Injury ·OWENS & MINOR DISTRIBUTION, INC.·Product code HFW·September 5, 2024

    DECANAV

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code DRF·May 7, 2025

    ALPHA TRANCELL DELUXE

    FDA Adverse Event
    Death ·ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB·Product code FNM·February 18, 2017

    TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

    FDA Adverse Event
    Malfunction ·ABIOMED, INC. - 1220648·Product code OZD·March 26, 2026

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code OAD·November 30, 2023

    Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distributed with pressure cuffs of varying sizes as accessories. Affected models include *2100-SX, 3000 series, 2017, 2016, 2015, 2014, 1059, 1059-A, *1059-C, *1058-C, 4000 series, 1100 series, 1060 series, 1080 series, 234 and 246. (* = current production model) All the devices are used in the study and diagnosis of vascular disease and blockages in the upper and lower extremities.

    FDA Enforcement
    Class II ·Terminated·Parks Medical Electronics, Inc·December 5, 2012

    FLOWTRON EXCEL / TRIO PUMPS

    FDA Adverse Event
    Injury ·GETINGE (SUZHOU) CO., LTD.·Product code KNM·August 15, 2013

    DEXCOM G7

    FDA Adverse Event
    Other ·DEXCOM, INC.·Product code QBJ·October 10, 2024

    IMPELLA

    FDA Adverse Event
    Death ·ABIOMED, INC. - 1220648·Product code OZD·March 5, 2026

    GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code PRL·July 3, 2025

    Devices includes a Multi Port Inflator or without Multi Port Inflator (MPI). All the devices are vascular blood flow machines. Devices are distributed with pressure cuffs of varying sizes as accessories. Affected models include *2100-SX, 3000 series, 2017, 2016, 2015, 2014, 1059, 1059-A, *1059-C, *1058-C, 4000 series, 1100 series, 1060 series, 1080 series, 234 and 246. (* = current production model) All the devices are used in the study and diagnosis of vascular disease and blockages in the upper and lower extremities.

    FDA Recall
    Terminated ·Parks Medical Electronics, Inc·Product code DPW·August 8, 2012

    Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003. Rx Only, Sterile

    FDA Recall
    Terminated ·Delfi Medical Innovations, Inc.·Product code KCY·April 3, 2019

    Trumpet, Needle Guide, Cat# TMS-200

    FDA Recall
    Open, Classified ·Technicality Inc.·Product code MDM·January 31, 2024