BEUDAMED
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    ETEST Telavancin (TLA) (0.002-32 ug/mL)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197087421·RICHTER HEATH Suture Clip Removal Forcep 140mm,...

    GM HELIX IMPLANT 6.0X10

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

    CONFORMIS TOTAL KNEE REPIAR SYSTEM (ITOTAL) TIBIAL COMPONENT: 6.0 MM THICKNESS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GYNECARE TVT ABBREVO CONTINENCE SYSTEM

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

    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

    GYNECARE TVT-ABBREVO MINI LCM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·November 30, 2021

    GM HELIX ACQUA IMPLANT 6.0X10

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

    SYNCHRON LX20 CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code CGA·July 1, 2011

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·June 20, 2013

    INTELECT ADVANCED COMBO MONOCHROME

    FDA Adverse Event
    Malfunction ·CHATTANOOGA GROUP·Product code IPF·September 29, 2008

    GM HELIX IMPLANT 6.0X8

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

    Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006 4. Allura Xper FD20 Biplane, Model Number 722008 5. Allura Xper FD10, Model Number 722010 6. Allura Xper FD10/10, Model Number 722011 7. Allura Xper FD20, Model Number 722012 8. Allura Xper FD20 Biplane, Model Number 722013 9. Allura Xper FD20 OR Table, Model Number 722023 10. Allura Xper FD10, Model Number 722026 11. Allura Xper FD10/10, Model Number 722027 12. Allura Xper FD20, Model Number 722028 13. Allura Xper FD20/10, Model Number 722029 14. Allura Xper FD20 OR Table, Model Number 722035 15. Allura Xper FD20/20, Model Number 722038 16. Allura Xper FD20/15, Model Number 722058 17. Allura Xper FD20/15 OR Table, Model Number 722059.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025