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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Genistrong

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

    GM HELIX IMPLANT 6.0X10

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·March 2, 2019

    MODIFICATION TO ENDOFAST RELIANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CLEARPOINT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    GM HELIX IMPLANT 6.0X8 MM

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·March 21, 2019

    GM HELIX IMPLANT 6.0X10

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·March 20, 2019

    ARTERIAL PRESSURE MONITORING TRAY

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQO·December 3, 2024

    GM HELIX ACQUA IMPLANT 6.0X10

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·March 18, 2019

    STERRAD 200, SINGLE DOOR

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·June 20, 2013

    WECK HEMOCLIPS

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code FZP·April 28, 2011

    FREESTYLE FREEDOM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA.·Product code LFR·September 23, 2008

    GM HELIX IMPLANT 6.0X8

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·June 17, 2019

    REVITAN, RASP, DISTAL, CURVED, 14/140

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code JDI·April 11, 2018

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018