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

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    Filters Regulation: Us FDA ×

    OxyPure Color Silicone Hydrogel Soft Contact Lenses

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    VARIOS 75

    FDA 510(k)
    FDA Class 2 ·Dental

    ZIMMER PERIARTICULAR SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

    FDA Adverse Event
    Injury ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 18, 2018

    VC10 PUMP, 115V

    FDA Adverse Event
    Malfunction ·GYRUS ACMI, INC.·Product code HHK·January 2, 2025

    AVIATOR ASSY FOUR LEVEL PLATE SIZE 68

    FDA Adverse Event
    Injury ·STRYKER SPINE-FRANCE·Product code KWQ·October 14, 2014

    OT VERIO IQ METER

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

    PROTIME MICROCOAGULATION SYSTEM

    FDA Adverse Event
    Malfunction ·INTERNATIONAL TECHNIDYNE CORP.·Product code GJS·June 30, 2011

    ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

    FDA Adverse Event
    Malfunction ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018

    AXIUM

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019

    AXIUM

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019

    AXIUM

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019

    AXIUM

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 11, 2019

    ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

    FDA Adverse Event
    Malfunction ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018

    ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

    FDA Adverse Event
    Death ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018

    ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

    FDA Adverse Event
    Malfunction ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 26, 2018

    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

    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