BEUDAMED
    13 results · 24ms · Sources: EU EUDAMED, US FDA

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    BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    AQUIFY LENS COMFORT DROPS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 16, 2017

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·June 1, 2018

    RESERVOIR 3ML

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code FRN·June 11, 2018

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 2, 2023

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 11, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    3.0MM TI CERVICAL SPINE LOCKING SCREW 16MM

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code OVE·July 23, 2013

    QUICK CHECK ONE

    FDA Adverse Event
    Other ·DIAGNOSTIC SOLUTIONS, INC.·Product code CFR·March 5, 1997

    Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (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