BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    Sofjec

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Bernafon

    FDA UDI
    Bernafon AG·05711584115046·CZ5 MNR, 2.4G NFM SABE/MSIL CORAL 5 GPL

    U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    REPROCESSED STRYKER ARTHROSCOPIC SHAVERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·August 31, 2018

    SYNERGY

    FDA Adverse Event
    Injury ·MEDTRONIC EUROPE SARL·Product code LGW·August 11, 2011

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIC NEUROMODULATION CORPORATION·Product code LGW·October 24, 2008

    INGENIO

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 9, 2013

    U BY KOTEX SLEEK

    FDA Adverse Event
    Malfunction ·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·June 27, 2018

    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

    DRX Revolution Mobile X-Ray System

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

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021