BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    Halyard ONE-STEP* Sterilization Wrap

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sonic

    FDA UDI
    Sonic Innovations, Inc.·05711583032979·ET20, KIT 312 NFM 85 L BE ENCHANT 20

    CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    2D PERFUSION

    FDA 510(k)
    FDA Class 2 ·Radiology

    TENDRIL ST.

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code NVN·January 13, 2014

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·June 27, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 4, 2011

    PERCUTANEOUS NEPHROSTOMY SET WITH SIMPLE LOOP VORTEK CATHETER

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code LJE·November 22, 2024

    PERCUTANEOUS NEPHROSTOMY SET WITH SIMPLE LOOP VORTEK CATHETER

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code LJE·November 22, 2024

    PERCUTANEOUS NEPHROSTOMY SET WITH SIMPLE LOOP VORTEK CATHETER

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code LJE·November 22, 2024

    PERCUTANEOUS NEPHROSTOMY SET WITH SIMPLE LOOP VORTEK CATHETER

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code LJE·November 22, 2024

    DELTA CER HEAD 12/14 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code LZO·March 19, 2018

    AQUAPAK 340 SW, 340 ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·February 18, 2015

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020