BEUDAMED
    15 results · 26ms · Sources: EU EUDAMED, US FDA

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    BICARBONATE REAGENTS AMRESCO PRODUCT #4326020

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SPEEDPASS DISPOSABLE

    FDA UDI
    Biomet Orthopedics, LLC·08428898885615·

    Clamp Chalazion Large

    FDA UDI
    BLINK MEDICAL LIMITED·05060480408104·

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776082949·V-Hook Suction Electrode

    UNICEM

    FDA 510(k)
    FDA Class 2 ·Dental

    DR180+OXY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TGS UKA FEMORAL AND TIBIAL OCMPONENTS

    FDA Adverse Event
    Injury ·ALEXANDRIA RESEARCH TECHNOLOGIES, LLC·Product code HSX·January 26, 2011

    UNICEL® DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JGS·November 20, 2010

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 1, 2014

    SM104 MSERIES W5TH WHL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·November 30, 2012

    XCELA PASV 5F DL 55CM IR-145 Nitinol Wire KIT PG, UPN H965251260, Catalog No. 25-126 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring.

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·December 20, 2017

    Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

    FDA Enforcement
    Class I ·Ongoing·Zyno Medical LLC·June 18, 2025

    OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370

    FDA Enforcement
    Class II ·Ongoing·Osteomed, LLC·December 15, 2021

    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