BEUDAMED
    18 results · 26ms · Sources: EU EUDAMED, US FDA

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    STOMA BONE SCREW

    FDA 510(k)
    FDA Class 2 ·Dental

    1.3MM SCREWDRIVER BLADE WITH HOLDING SLEEVE

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·August 19, 2019

    AUTOBONE

    FDA 510(k)
    FDA Class 2 ·Radiology

    INTERLAB MICROCAL SERUM CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SEDLINE KIT

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code MWI·December 7, 2017

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 4, 2025

    V-GO DISPOSABLE INSULIN DEVICE

    FDA Adverse Event
    Malfunction ·ZEALAND PHARMA U.S. INC.·Product code LZG·May 25, 2022

    ATTAIN OTW

    FDA Adverse Event
    Injury ·MPRI·Product code LWP·April 10, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·March 15, 2011

    ONE TOUCH ULTRAMINI METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·May 21, 2008

    CROSS LOCKING DRILL BUSHING

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code MDM·February 4, 2016

    GUIDE BUSHING TROCHANTERIC

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code MDM·February 4, 2016

    LAG SCREW DRILL BUSHING STD.

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code MDM·February 4, 2016

    GUIDE TUBE TROCHANTERIC

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code MDM·February 4, 2016

    GUIDE TUBE TROCHANTERIC

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code MDM·February 4, 2016

    SOLID LAG SCREW REAMER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code MDM·December 29, 2015

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018