BEUDAMED
    12 results · 24ms · Sources: EU EUDAMED, US FDA

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    REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY

    FDA 510(k)
    FDA Unclassified ·Unknown

    MODIFICATION TO UNITY NETWORK ID

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    INION OTPS BIOABSOBABLE FREEDOMPLATE

    FDA Adverse Event
    Injury ·INION OY·Product code HRS·November 18, 2014

    INION OTPS BIOABSOBABLE FREEDOMPLATE

    FDA Adverse Event
    Injury ·INION OY·Product code HRS·May 14, 2015

    INION OTPS BIOABSORBABLE FREEDOMPLATE

    FDA Adverse Event
    Injury ·INION OY·Product code HRS·March 19, 2015

    CASHMERE 14 - PLATINUM MICROCOIL

    FDA Adverse Event
    Injury ·MICRUS ENDOVASCULAR, LLC·Product code HCG·May 29, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·June 9, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·August 20, 2008

    INION OTPS BIOABSORBABLE FREEDOMPLATE

    FDA Adverse Event
    Injury ·INION OY·Product code HRS·June 5, 2015

    Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053

    FDA Enforcement
    Class II ·Ongoing·AtriCure, Inc.·February 7, 2024

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015