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

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    SafeR Syringe and SafeR Sting

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Disposable Blade

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113196·BARD-PARKER BLADE #11 PACK OF 50

    BENCO

    FDA UDI
    BENCO DENTAL SUPPLY CO.·00366975004307·#70 Green .02 Taper Benco Dental Gutta Percha P...

    IQ FLEX M

    FDA Adverse Event
    Malfunction ·FIRST SOURCE INC.·Product code IZL·May 29, 2024

    ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IVENT 201 PORTABLE VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SILASTIC MAMMARY IMPLANT, ROUND, NFP

    FDA Adverse Event
    Injury ·DOW CORNING CORPORATION·Product code FTR·January 13, 1998

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·November 3, 2014

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·August 17, 2011

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 3, 2013

    CODMAN Disposable Perforator 11mm. Cranial Perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·November 12, 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