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

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    Filters Classification: Class Ii ×

    Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes

    FDA Enforcement
    Class II ·Terminated·Acumedia Manufacturers, Inc.·February 1, 2017

    Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.

    FDA Enforcement
    Class II ·Ongoing·Maquet Cardiopulmonary Gmbh·August 6, 2025

    KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. Model (Ref) #: 4220005

    FDA Enforcement
    Class II ·Ongoing·Straumann USA LLC·September 1, 2021

    KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011

    FDA Enforcement
    Class II ·Ongoing·Keystone Industries·January 10, 2024

    Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Manual #1528403. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.

    FDA Enforcement
    Class II ·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015

    Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.

    FDA Enforcement
    Class II ·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015

    Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual #1441784. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.

    FDA Enforcement
    Class II ·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015

    Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia SD, User Manual #1400191. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.

    FDA Enforcement
    Class II ·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015

    Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia HD, User Manual #1513140. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.

    FDA Enforcement
    Class II ·Terminated·Trumpf Medical Systems, Inc.·August 19, 2015

    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).

    FDA Enforcement
    Class II ·Terminated·ConMed Corporation·April 4, 2018

    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).

    FDA Enforcement
    Class II ·Terminated·ConMed Corporation·April 4, 2018

    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).

    FDA Enforcement
    Class II ·Terminated·ConMed Corporation·April 4, 2018

    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog Number 2602M Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).

    FDA Enforcement
    Class II ·Terminated·ConMed Corporation·April 4, 2018

    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog Number 2602Z Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).

    FDA Enforcement
    Class II ·Terminated·ConMed Corporation·April 4, 2018

    Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Mindray V21 Size: 515 mm X 335 mm X 685 mm N.W.: 8 kg G.W.: 11 kg Qty:1 Manufactured in China One product, V Series monitor, available in two sizes: The V12 has a 12 inch screen, the V21 has a 21 inch screen. The V Series Monitor is a Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. It also monitors of the following human physiological parameters: 1) ECG waveform derived from 3, 5, 6 and 12 lead measurements, 2) Heart Rate, 3) Pulse Oximetry (Sp O2), 4) ST Segment Analysis, 5) Arrhythmia Detection, 6) Non Invasive Blood Pressure (NIBP), 7) Invasive Blood Pressure (IBP), 8) Cardiac Output (CO), 9) Respiratory Gasses, 10) Respiration Rate, 11) Temperature, It is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.

    FDA Enforcement
    Class II ·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·December 26, 2012

    DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361

    FDA Enforcement
    Class II ·Ongoing·DRG International, Inc.·January 22, 2025

    Total Thyroxine (T4) ELISA; REF EIA-1781

    FDA Enforcement
    Class II ·Ongoing·DRG International, Inc.·December 8, 2021

    C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293

    FDA Enforcement
    Class II ·Terminated·DRG International, Inc.·April 13, 2022

    Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.

    FDA Enforcement
    Class II ·Terminated·DRG Instruments GmbH·August 22, 2018

    DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic

    FDA Enforcement
    Class II ·Terminated·DRG Instruments GmbH·September 4, 2019