BEUDAMED
    18 results · 29ms · Sources: EU EUDAMED, US FDA

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    GenePOC Strep A

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Padded Arm Sling

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357833665·

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515028678·Initial Incision Retractor, large blade, 1 x 2"

    MobileLink Acetabular Cup System

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575189526·UHMWPE Inserts -E-Dur; Standard (Neutral)

    MobileLink Acetabular Cup System

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575189519·UHMWPE Inserts -E-Dur; Standard (Neutral)

    MobileLink Acetabular Cup System

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575189502·UHMWPE Inserts -E-Dur; Standard (Neutral)

    LEUCADIA AUTOLOK PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RT600

    FDA 510(k)
    FDA Class 2 ·Neurology

    EKOSONIC ENDOVASCULAR DEVICE, 135X12CM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023

    EKOSONIC ENDOVASCULAR DEVICE, 135X12CM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023

    EKOSONIC ENDOVASCULAR DEVICE, 106X12CM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·March 1, 2023

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 18, 2014

    ANGIOGRAPHY PACK

    FDA Adverse Event
    Malfunction ·DEROYAL·Product code DQY·July 21, 2011

    ASR UNI FEMORAL IMPL SIZE 45

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·June 21, 2013

    EKOSONIC ENDOVASCULAR DEVICE, 106X18CM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023

    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

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

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

    Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20)

    FDA Enforcement
    Class II ·Terminated·Philips North America Llc·November 17, 2021