BEUDAMED
    22 results · 23ms · Sources: EU EUDAMED, US FDA

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    Pre-Filled Normal Saline Flush Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Med Spec Boxer Splint

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357235841·

    SYNGO, CT BONE READING

    FDA 510(k)
    FDA Class 2 ·Radiology

    ASCENSIA DEX 2 DIABETES CARE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GMK SPHERE CEMENTLESS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·May 25, 2026

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 21, 2024

    GMK 3D METAL TIBIAL TRAY

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 12, 2025

    GMK SPHERIKA CEMENTLESS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·March 16, 2026

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008

    ACCU-CHEK ® AVIVA

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code NBW·August 25, 2011

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code LWS·July 12, 2013

    GMK SPHERIKA CEMENTLESS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·December 19, 2025

    GMK SPHERIKA CEMENTLESS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MBH·December 24, 2025

    GMK 3D METAL TIBIAL TRAY

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 11, 2025

    GMK 3D METAL TIBIAL TRAY

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 29, 2025

    BD CATHENA¿ SAFETY IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·July 7, 2022

    2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 32MM

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code HWC·September 11, 2017

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Azurion 7 B20, Model Number 722068. 5. Azurion 7 M12, Model Number 722078. 6. Azurion 7 M20, Model Number 722079. 7. Azurion 3 M12, Model Number 722221. 8. Azurion 3 M15, Model Number 722222. 9. Azurion 7 M12, Model Number 722223. 10. Azurion 7 M20, Model Number 722224. 11. Azurion 7 B12, Model Number 722225. 12. Azurion 7 B20, Model Number 722226. 13. Azurion 5 M12, Model Number 722227. 14. Azurion 5 M20, Model Number 722228. 15. Azurion 7 M20, Model Number 722282.

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