BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

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    RF Vapor System

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

    HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY

    FDA 510(k)
    FDA Unclassified ·Unknown

    SONOACE SA-8000 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SOLEX® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE HEPARIN EU

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code NCX·March 12, 2026

    WINGSPAN STENT SYSTEM

    FDA Adverse Event
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.·Product code NJE·October 23, 2008

    OT VERIO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 16, 2011

    FLEXTEND

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 9, 2013

    LINER FOR METAL BACK GLENOID STANDARD

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWS·December 22, 2021

    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