BEUDAMED
    22 results · 27ms · Sources: EU EUDAMED, US FDA

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    NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776123673·Yasargil Bayonet Forceps

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361009375·PedFuse, Adjustable Cross Connector, Angled, 55mm

    RHIGENE MESACUP2 TEST- SM

    FDA 510(k)
    FDA Class 2 ·Immunology

    MPW HEMODIALYSIS WATER PURIFICATION SYSTEM

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

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/10 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 7, 2021

    RHK SEGMENTAL SHORT YOKE

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDI·December 7, 2016

    NI

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·May 13, 2022

    VENTED MICRO VOL.INLET, N/S

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·March 28, 2022

    VALVE SET, EM2400

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·April 7, 2022

    VALVE SET, EM2400

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·August 8, 2022

    ONYX

    FDA Adverse Event
    Injury ·EV3 NEUROVASCULAR·Product code MFE·March 13, 2013

    LIGAMAX-5MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·February 28, 2011

    2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·February 26, 2008

    250 ML TPN BAG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·May 21, 2021

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 2, 2021

    EXACTA-MIX 2400 COMPOUNDING SYSTEM

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code NEP·February 27, 2023

    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM1.S Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.SR Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA Used in direct monitoring of the partial pressure of oxygen.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·October 30, 2013

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013