BEUDAMED
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    REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162

    FDA 510(k)
    FDA Class 2 ·Dental

    Safco Micro Applicators

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310206463·Safco micro applicator sf orange 100

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717108617·Midway Select Impression Material

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450090756·

    ABX MICROS CRP

    FDA 510(k)
    FDA Class 2 ·Hematology

    DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE

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

    BIOLOX HEAD HIP

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code LZO·December 18, 2020

    EMERGE¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·March 26, 2013

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·March 16, 2011

    STANDARD COMPRESSION PLATE BROAD

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS SELZACH·Product code HRS·March 27, 2008

    BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog No:75-019 The BioFlo PICCs with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·December 14, 2016

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016