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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS

    FDA 510(k)
    FDA Class 2 ·Dental

    INTEGRA BONE FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ImmersiveTouch3 and MicrovisTouch

    FDA 510(k)
    FDA Class 2 ·Radiology

    RANAWAT/BURSTEIN COCR CEMENT FEMORAL STEM SIZE 6

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·July 31, 2017

    RANAWAT/BURSTEIN RINGLOC SHELL

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·July 31, 2017

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·January 16, 2013

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 23, 2010

    X3 TRIATHLON CS INS SIZE 4 9MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·July 17, 2014

    Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·May 16, 2018