BEUDAMED
    11 results · 29ms · Sources: EU EUDAMED, US FDA

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    ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS

    FDA 510(k)
    FDA Class 2 ·Radiology

    PRIMUS AESTHETIC PLATFORM

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

    MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664

    FDA 510(k)
    FDA Class 2 ·Radiology

    LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LJS·August 24, 2016

    EP DIAGNOSTIC CATHETER QUADRIPOLAR D-TYPE/BLUE

    FDA Adverse Event
    Malfunction ·STERILMED, INC.·Product code NLH·September 14, 2020

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 29, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

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

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·PURITAN BENNETT CORP.·Product code CBK·August 20, 2008

    UNKNOWN PFM-R DISTAL STEM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code JDI·March 13, 2018

    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