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

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    Respiratory Gating for Scanners v2.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    SHARPS COLL 6GAL RED 1103 NON-VENT CAP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·May 10, 2019

    MINI SHOPPER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Nitrile examination gloves

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Death ·CORDIS DE MEXICO·Product code NIQ·October 28, 2008

    ASR 300 SPIKED CUP SIZE 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS LLC (PR)·Product code NIQ·July 9, 2013

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    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