BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    SafeOp 2: Neural Informatix System

    FDA 510(k)
    FDA Class 2 ·Neurology

    TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS

    FDA 510(k)
    FDA Class 2 ·Radiology

    HQS INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS LLC (PR)·Product code NIQ·October 28, 2008

    CORE SABER DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·August 4, 2011

    AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - ANTERIOR

    FDA Adverse Event
    Injury ·BARD SHANNON LIMITED·Product code FTL·July 3, 2013

    HUMAPEN MEMOIR

    FDA Adverse Event
    Malfunction ·ELI LILLY AND COMPANY·Product code NSC·April 5, 2010

    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