BEUDAMED
    17 results · 24ms · Sources: EU EUDAMED, US FDA

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    HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux

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

    GM HELIX ACQUA IMPLANT,TI,5.0X16

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·May 16, 2018

    SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MICROSCAN MICROSTEP

    FDA 510(k)
    FDA Class 2 ·Microbiology

    GM HELIX IMPLANT 4.3X13

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·June 6, 2018

    GM HELIX IMPLANT 4.3X13

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·June 22, 2018

    GM DRIVE ACQUA IMPLANT 3.5X8 MM

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·August 29, 2018

    GM HELIX ACQUA IMPLANT 3.75X11.5

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·April 24, 2018

    GM HELIX IMPLANT 3.5X10

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·June 29, 2018

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 8, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 24, 2025

    GM HELIX ACQUA IMPLANT 3.5X11.5

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·April 24, 2018

    GM DRIVE IMPLANT 3.5X10

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·April 20, 2018

    RESTORE

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 11, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 13, 2011

    HIRES 90K

    FDA Adverse Event
    Malfunction ·ADVANCED BIONICS LLC·Product code MCM·September 12, 2008

    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