BEUDAMED
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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    16.5CM MICRO REVISION ATTACH, BLACK MAX

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·May 10, 2017

    22CM MICRO REVISION ATTACH, BLACK MAX

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·May 10, 2017

    9.4CM MICRO REVISION ATTACH, BLACK MAX

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·May 10, 2017

    Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; For use in primary total hip arthroplasty.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·June 8, 2016

    Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup), Catalog Number 140-01-54; For use in primary total hip arthroplasty.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·June 8, 2016

    Canon Vantage Galan 3T, REF: MRT-3020 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.

    FDA Enforcement
    Class II ·Ongoing·Canon Medical System, USA, INC.·July 21, 2021

    Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.

    FDA Enforcement
    Class II ·Ongoing·Canon Medical System, USA, INC.·July 21, 2021

    Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.

    FDA Enforcement
    Class II ·Ongoing·Canon Medical System, USA, INC.·July 21, 2021

    Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI System, REF: MRT-1504 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.

    FDA Enforcement
    Class II ·Ongoing·Canon Medical System, USA, INC.·July 21, 2021

    Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017

    Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·February 28, 2024

    Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment..

    FDA Enforcement
    Class II ·Terminated·Mar Cor Purification·March 26, 2014

    Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be used in surgery on fingers or toes to provide a blood-less field.

    FDA Enforcement
    Class II ·Terminated·Mar-Med Co·February 10, 2021

    Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.

    FDA Enforcement
    Class II ·Terminated·Mar Cor Purification·March 19, 2014

    Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106. Product Usage: The CWP is a Central reverse osmosis system with the intended use of producing water for dialysis of multiple patients.

    FDA Enforcement
    Class II ·Terminated·Mar Cor Purification·May 14, 2014

    NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL GSP30-SWE-INTL GSP30-ENG-INT GSP30-MAL-INTL GSP30-SPA-INT NasoGel Spray is a saline-based gel formula that can be sprayed to moisturize and lubricate dry and irritated anterior or front of nasal passages caused by dry climate and indoor heat.

    FDA Enforcement
    Class II ·Ongoing·Neilmed Pharmaceuticals Inc·February 12, 2025

    T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Usage: Flush syringe.

    FDA Enforcement
    Class II ·Terminated·MRP, LLC dba AMUSA·June 24, 2015

    0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage: Flush syringe.

    FDA Enforcement
    Class II ·Terminated·MRP, LLC dba AMUSA·June 10, 2015

    0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.

    FDA Enforcement
    Class II ·Terminated·MRP, LLC dba AMUSA·September 2, 2015

    Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07

    FDA Enforcement
    Class II ·Terminated·New Era Orthopaedics, LLc·August 15, 2018