BEUDAMED
    83 results · 10ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or vessel.

    FDA Enforcement
    Class II ·Terminated·Numed Inc·December 5, 2018

    Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or vessel.

    FDA Enforcement
    Class II ·Terminated·Numed Inc·December 5, 2018

    BIB Balloon in Balloon Dilatation Catheter. Model Number: 420

    FDA Enforcement
    Class II ·Terminated·Numed Inc·May 21, 2025

    ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 16, 2018

    TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., Irvine, CA.

    FDA Enforcement
    Class II ·Terminated·Tekia, Inc.·December 25, 2019

    Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.

    FDA Enforcement
    Class II ·Terminated·Argon Medical Devices, Inc·November 13, 2019

    Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-sterile. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.

    FDA Enforcement
    Class II ·Terminated·Argon Medical Devices, Inc·November 13, 2019

    Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.

    FDA Enforcement
    Class II ·Terminated·LivaNova USA Inc·February 5, 2020

    Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.

    FDA Enforcement
    Class II ·Terminated·LivaNova USA Inc·February 5, 2020

    Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.

    FDA Enforcement
    Class II ·Terminated·Alcon Research LLC·April 29, 2020

    Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.

    FDA Enforcement
    Class II ·Terminated·Argon Medical Devices, Inc·November 13, 2019

    Argon Medical Devices Plugs, Male/Female Luer Lock Plug, REF 041295000A, 50/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.

    FDA Enforcement
    Class II ·Terminated·Argon Medical Devices, Inc·November 13, 2019

    Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, cemented Device Common Name: Sirius Femoral Stem The Biomet's Sirius Femoral Hip Stem is a double-tapered, highly polished cemented hip stem, designed for either primary or revision surgery. A distal centralizer is provided for optimal placement within the femoral canal. The system is used with Type 1 taper modular heads and compatible acetabular shells/liners and screws to provide a total hip replacement system.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·December 24, 2014

    Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel Inc., Lenexa, KS.

    FDA Enforcement
    Class II ·Terminated·Remel Inc·July 23, 2014

    iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·July 10, 2019

    ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.

    FDA Enforcement
    Class II ·Terminated·Ellex iScience, Inc.·October 10, 2018

    Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Stopcock, REF 041230001A, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.

    FDA Enforcement
    Class II ·Terminated·Argon Medical Devices, Inc·November 13, 2019

    Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 5303151, XR-5154323 -- Carestream Health, Inc. Made in France -- --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major components: x-ray tube, x-ray generator, collimator and image receptor. These systems are permanently installed diagnostic dental x-ray systems for generation of x-rays for examination of the teeth, jaw and oral structures.

    FDA Enforcement
    Class II ·Terminated·Carestream Health Inc.·March 12, 2014

    Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·September 20, 2017

    Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major components: x-ray tube, x-ray generator, collimator and image receptor. These systems are permanently installed diagnostic dental x-ray systems for generation of x-rays for examination of the teeth, jaw and oral structures.

    FDA Enforcement
    Class II ·Terminated·Carestream Health Inc.·March 12, 2014