BEUDAMED
    15 results · 19ms · Sources: EU EUDAMED, US FDA

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    STAT DIFF STAIN

    FDA 510(k)
    FDA Class 1 ·Hematology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517330383·CoRoent® SI Ta Markers, 7x17x14 7° Con

    CONNECTOR

    FDA UDI
    Orthofix US LLC·18257200125319·CONNECTOR COUNTER TORQUE WRENCH

    Sklar

    FDA UDI
    SKLAR CORPORATION·10649111339899·PAPAVERO CASPAR SPEC 100X15MM

    AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems

    FDA 510(k)
    FDA Class 2 ·Radiology

    SCORPIO PS FEMUR WAFFLE POSTS W/LFIT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·July 21, 2010

    ATLAS II PLUS DR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·May 5, 2014

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2012

    INRATIO

    FDA Adverse Event
    Malfunction ·BIOSITE INCORPORATED·Product code GJS·July 29, 2010

    PALL ULTIPOR 25 BREATHING SYSTEM FILTER

    FDA Adverse Event
    Injury ·PALL NEWQUAY·Product code CAH·July 13, 2018

    PALL ULTIPOR 100 BREATHING SYSTEM FILTER

    FDA Adverse Event
    Injury ·PALL NEWQUAY·Product code CAH·April 18, 2017

    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

    ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025