BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

    FDA 510(k)
    FDA Class 2 ·Radiology

    SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT

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

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·October 25, 2014

    X-STOP

    FDA Adverse Event
    Malfunction ·MEDTRONIC SPINE LLC·Product code NQO·August 1, 2011

    FINELINE II

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

    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