BEUDAMED
    11 results · 35ms · Sources: EU EUDAMED, US FDA

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    PLAZLYTE(TM)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ERA Implant® Surgical Kit, Complete

    FDA UDI
    STERNGOLD DENTAL LLC·00841549114526·The ERA Implant Surgical Kit consists of variou...

    3M™ Victory Series™

    FDA UDI
    3M UNITEK CORPORATION·00652221112729·3M™ Victory Series™ Second Molar Bands, 905-119...

    OHMEDA MODULUS CD ANESTHESIA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LATEX PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·January 9, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 22, 2010

    ACCU-CHEK ® COMPACT PLUS TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 1, 2014

    Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX 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

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024