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

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    SEA-BAND

    FDA 510(k)
    FDA Unclassified ·Unknown

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033268·Baltic Denture System BDLoad BDLoad Sm6 PLSEbm...

    PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Z-TOUCH

    FDA 510(k)
    FDA Class 2 ·Neurology

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·June 16, 2006

    NO CODE AVAILABLE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code GXN·March 8, 2016

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·November 20, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Death ·MEDTRONIC MINIMED·Product code OYC·April 3, 2013

    AURA XP

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS·Product code GEX·March 24, 2011

    SILVER BOLT SCREWS

    FDA Adverse Event
    Malfunction ·VERTIFLEX, INC.·Product code HWC·March 26, 2008

    POLYMOBIL PLUS

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE GMBH·Product code IZL·July 27, 2023

    PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code GWO·June 21, 2016

    Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·April 29, 2020

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021