BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    Disposable Powder Free Vinyl Exam Glove, Clear/Yellow

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SCHWERT

    FDA UDI
    A. Schweickhardt GmbH & Co. KG·E8961705750·Knife, periodontic, Fig. 1 Double...

    SCHWERT

    FDA UDI
    A. Schweickhardt GmbH & Co. KG·E89617057507E0·Knife, periodontic, Fig. 1 Double...

    LDR SPINE USA SPINE TUNE TL SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EVICEL APPLICATION DEVICE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    S5 ROLLER PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·October 1, 2014

    HEARTSTART MRX -EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 28, 2013

    LIBERTE' CORONARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code MAF·July 21, 2011

    MICRUSFRAME14 4MM X 8CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·August 30, 2021

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024