BEUDAMED
    14 results · 37ms · Sources: EU EUDAMED, US FDA

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    SYSTEMATE CALCIUM (EPOS APPLICATION) #65409

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GENTLE THREADS THREADED DILATOR

    FDA UDI
    Biomet Orthopedics, LLC·00880304407114·

    Gentle Threads™

    FDA UDI
    Biomet Orthopedics, LLC·00887868568084·

    STAGE III

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TITANIUM GREENFIELD(R) VENA CAVA FILTER W/HOOKS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 9, 2013

    RENAL - DISPOSABLE

    FDA Adverse Event
    Injury ·Product code KDJ·November 23, 2010

    ENDOTAK ENDURANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code LWS·July 1, 2014

    STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - CORK·Product code DTK·May 14, 2013

    Monoject Blunt Cannula, 15 G x 1-1/2" (1.829 mm x 3.8 cm) Item code: 8881202314

    FDA Enforcement
    Class II ·Completed·Cardinal Health 200, LLC·July 31, 2019

    Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·May 20, 2015

    Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143. Used to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·May 7, 2014

    Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·May 20, 2015

    Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017