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

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    ROSA® Knee System

    FDA 510(k)
    FDA Class 2 ·Neurology

    ScrewPlus® Implant

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307105602·3.7mmD x 8mmL, 4.7mmD Platform

    RIGIDFIX

    FDA UDI
    Medos International Sàrl·10886705003020·RIGIDFIX Femoral Rod Soft Tissue Only 8mm, 30-1...

    ORTHOSCAN MOBILE DI MINI C-ARM

    FDA 510(k)
    FDA Class 2 ·Radiology

    REFERENCE CHECK, CATALOG NUMBER-RCN-10

    FDA 510(k)
    FDA Class 2 ·Hematology

    MICROCHOICE BUR GUARD, MEDIUM

    FDA Adverse Event
    Other ·CONMED LINVATEC·Product code EQJ·October 21, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·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