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

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    MSD CRP Assay Kit and MESO SECTOR S 700 Instrument

    FDA 510(k)
    FDA Class 2 ·Immunology

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704293548·

    SUBTALAR IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FATHOM (TM) 14 STEERABLE GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 21, 2011

    OT VERIO TEST STRIPS

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013

    ARCHITECT I2000SR ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JJE·September 17, 2008

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·July 26, 2024

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·August 23, 2021

    ULTRATHANE SUPRAPUBIC CATHETER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KOB·August 23, 2022

    ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·January 19, 2021

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·March 17, 2022

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·March 17, 2022

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·March 17, 2022

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·March 17, 2022

    ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020

    ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·August 23, 2021

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·July 21, 2021

    CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·October 27, 2021