BEUDAMED
    17 results · 23ms · Sources: EU EUDAMED, US FDA

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    KSEA MEDI PACK

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

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113561·IMPLANT BLADE 6.2MM (BX/5)

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 30, 2021

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 30, 2021

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·April 30, 2021

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·June 29, 2021

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·June 18, 2021

    ORION DIGITAL IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    FR MARSEILLE

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·December 22, 2010

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON)·Product code FTL·March 20, 2013

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code INK·February 15, 2011

    LUPINE DRILL GUIDE

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code HRX·March 31, 2008

    Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems, Regulation Number 21 CPR 892.1000, Regulatory Class II, Product Code 90-LNH and was cleared with K032490

    FDA Recall
    Terminated ·Toshiba American Med Sys Inc·Product code LNH·October 12, 2005

    UNK

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·July 22, 2011

    FR VILLEURBANNE

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·December 22, 2010

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012