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

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    VITA VM 7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, MODEL NX98

    FDA 510(k)
    FDA Class 2 ·Dental

    FREELITE KAPPA FREE KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    BODYGUARD

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·December 23, 2008

    COCR HEAD S 36/-4 TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code JDI·September 27, 2021

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 10, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 4, 2014

    ZIMMER M/L TAPER HIP PROSTHESIS FEMORAL STEM PRESS-FIT PLASMA SPRAYED NECK TAPER

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWY·June 13, 2008

    XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code NIQ·February 17, 2021

    XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code NIQ·February 17, 2021

    Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infusion of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions, and other therapeutic fluids.

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·November 30, 2022