BEUDAMED
    25 results · 7ms · Sources: EU EUDAMED, US FDA

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    I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.

    FDA Enforcement
    Class II ·Terminated·I-Flow LLC·June 12, 2013

    I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.

    FDA Enforcement
    Class II ·Terminated·I-Flow LLC·June 12, 2013

    ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208

    FDA Enforcement
    Class II ·Completed·Materialise USA LLC·August 31, 2022

    On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33

    FDA Enforcement
    Class II ·Ongoing·On-X Life Technologies, Inc.·May 20, 2026

    Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair.

    FDA Enforcement
    Class II ·Terminated·On-X Life Technologies, Inc.·February 1, 2017

    Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·October 7, 2015

    The EKOS cart has the catalog number 700-60101. The EKOS cart is a custom infusion stand/cart used to hold and transport the EkoSonic Control Unit. The cart is designed with three poles to hold infusion pumps and fluid bags, a tray on which the EkoSonic Control unit sits and a base designed to hold an Uninterruptable Power Supply (UPS). The cart mounts on 4 wheels, two locking and two non-locking.

    FDA Enforcement
    Class II ·Terminated·EKOS Corporation·October 5, 2016

    VACUETTE SAFELINK, REF: 450210

    FDA Enforcement
    Class II ·Ongoing·Greiner Bio-One GmbH·January 15, 2025

    3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes.

    FDA Enforcement
    Class II ·Terminated·Greiner Bio-One North America, Inc.·August 15, 2012

    VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood. VACUETTE tubes are used to collect, transport, and process blood for testing serum, plasma, or whole blood in the clinical laboratory.

    FDA Enforcement
    Class II ·Terminated·Greiner Bio-One North America, Inc.·January 29, 2020

    VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.

    FDA Enforcement
    Class II ·Terminated·Greiner Bio-One North America, Inc.·April 22, 2020

    Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged

    FDA Enforcement
    Class II ·Terminated·Greiner Bio-One North America, Inc.·September 29, 2021

    Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is intended to be used only with Vacuette Blood collection Tubes as a system in routine venipuncture procedures. They are for single-use only and should only be used by adequately trained healthcare personnel in accordance with instructions for use.

    FDA Enforcement
    Class II ·Terminated·Greiner Bio-One North America, Inc.·July 11, 2012

    4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolytic agent, sodium fluoride, and an anticoagulant, potassium oxalate. The product is suitable for the analysis of blood glucose and lactate

    FDA Enforcement
    Class II ·Terminated·Greiner Bio-One North America, Inc.·June 15, 2016

    VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures.

    FDA Enforcement
    Class II ·Terminated·Greiner Bio-One North America, Inc.·February 27, 2013

    VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P - Product Usage: are used to collect, transport, and process blood for testing serum, plasma or whole blood in the clinical laboratory.

    FDA Enforcement
    Class II ·Terminated·Greiner Bio-One North America, Inc.·October 7, 2020

    VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged - Product Usage: indicated for use in collection and transport of venous whole blood for coagulation testing.

    FDA Enforcement
    Class II ·Terminated·Greiner Bio-One North America, Inc.·May 12, 2021

    VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged

    FDA Enforcement
    Class II ·Terminated·Greiner Bio-One North America, Inc.·October 6, 2021

    greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P

    FDA Enforcement
    Class II ·Terminated·Greiner Bio-One North America, Inc.·January 26, 2022

    VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.

    FDA Enforcement
    Class II ·Ongoing·Greiner Bio-One North America, Inc.·January 24, 2024