BEUDAMED
    20 results · 35ms · Sources: EU EUDAMED, US FDA

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    MTS Omadacycline 0.002 - 32 ug/mL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Pedo Reverse Pull Face Mask

    FDA UDI
    FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC·D8282200180·

    ATLANTIS® Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000889647·PLATE 7200180 ATL VISION ELITE 80MM

    ATLANTIS® Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994625007·PLATE 7200180 ATL VISION ELITE 80MM

    MICRO FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896060418·MICRO FORCEPS STRAIGHT TUNGSTEN CARBIDE DUST TI...

    Monkey Rings™ External Fixation System

    FDA UDI
    Paragon 28, Inc.·00889795115621·5/8 Ring - 180mm

    RELIEFBAND DEVICE, MODELS RB-DL, RB-EL, RB-RL

    FDA 510(k)
    FDA Class 2 ·Neurology

    TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Widex

    FDA UDI
    Widex A/S·05706069305135·RC4 version 2 (Fashion grey, no bat )

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 29, 2016

    MEDTRONIC TRANSCATHETER VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·February 14, 2023

    PFC SIGMARP STB TB IN 3 12.5

    FDA Adverse Event
    Injury ·DEPUY IRELAND 9616671·Product code NJL·October 24, 2014

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code OAD·August 10, 2011

    PROFEMUR(R) MODULAR FEMORAL NECK

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LWJ·July 1, 2013

    H-MAX S STANDARD FEM. STEM #13

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code MEH·December 18, 2018

    VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories-- Product Code (Unique Identifier): 6199920 (10758750033362)

    FDA Enforcement
    Class II ·Terminated·Ortho Clinical Diagnostics Inc·November 25, 2020

    Mutlidiagnost-Eleva with Flat Detector 708034 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Nederlands·May 9, 2018

    MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·August 10, 2016

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    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