BEUDAMED
    17 results · 23ms · Sources: EU EUDAMED, US FDA

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    ULab Systems uDesign Software

    FDA 510(k)
    FDA Class 2 ·Dental

    N/A

    FDA UDI
    INNOVATIVE HEALTH LLC·10841898121364·EP XT Steerable Diagnostic EP Catheter, 6F

    N/A

    FDA UDI
    STRYKER SUSTAINABILITY SOLUTIONS, INC.·00885825003685·Steerable Diagnostic EP Catheter , LARGE 4.0, 6...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694045070·SmartFlex 5mm Rongeur

    N/A

    FDA UDI
    STRYKER SUSTAINABILITY SOLUTIONS, INC.·00885825003692·Steerable Diagnostic EP Catheter , LARGE 4.0, 6...

    OMEGA II SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    RETRACTA DETACHABLE EMBOLIZATION COIL

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRD·November 29, 2022

    AUVON TENS & EMS DEVICE

    FDA Adverse Event
    Injury ·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·January 28, 2025

    QUICK SET PARADIGM

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·November 2, 2009

    QUICK SET PARADIGM

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·November 2, 2009

    M2A-MAGNUM MOD HD SZ 52MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·October 24, 2014

    GORE HYBRID VASCULAR GRAFT

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code DSY·July 28, 2011

    ASR ACETABULAR IMPLANT 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·July 1, 2013

    AUVON TENS UNIT

    FDA Adverse Event
    Injury ·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·December 19, 2024

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016