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

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    EarlyVue VS30

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EARLYVUE VS30 VITAL SIGNS MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS NORTH AMERICA LLC·Product code DSJ·September 15, 2021

    EARLYVUE VS30 VITAL SIGNS MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS NORTH AMERICA LLC·Product code DSJ·March 1, 2022

    EARLYVUE VS30 VITAL SIGNS MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS NORTH AMERICA LLC·Product code DSJ·August 1, 2022

    EARLYVUE VS30 VITALS MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code DSJ·June 14, 2021

    EARLYVUE VS30 VITALS MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·July 29, 2021

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017958·K-Wire, Double Ended, Trocar Point, Diameter 0....

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017941·K-Wire, Double Ended, Trocar Point, Diameter Si...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319741665·Adson Suction Tube 6" (15cm), with finger valve...

    INVENDO C20 COLONOSCOPY SYSTEM

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

    COOK MREYE EMBOLIZATION COILS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    M2A-MAGNUM PF CUP 56ODX50ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 26, 2013

    ESPRIT VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·October 6, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

    BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020