BEUDAMED
    13 results · 25ms · Sources: EU EUDAMED, US FDA

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    Levator Elite (Model LE9011)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Vitique

    FDA UDI
    DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG2130431·Highly esthetic permanent composite luting ceme...

    Metra Unitized Pack - ZLB

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588130439·Metra Unitized Pack - ZLB

    DIRECT ANTIBIOTIC INFUSION KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CANDELA CLEARBEAM PULSED DYE LASER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SJM EPIC SUPRA TISSUE VALVE

    FDA Adverse Event
    Death ·ST JUDE MEDICAL BRASIL LTDA.·Product code LWR·October 24, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

    INCEPTA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 9, 2013

    INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·July 4, 2019

    MAGNETOM Cima.X (DE). Model Number: 11647158.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017

    Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (722068, 722226, 722236), Azurion 7 M12 (722078, 722223, 722233), Azurion 7 M20 (722079, 722224, 722234, 722282).

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 20, 2026

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023