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

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    Filters Classification: Class Ii × Status: Terminated × 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

    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

    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

    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

    Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·July 31, 2013

    BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·December 26, 2012

    Arkon Anesthesia Delivery System, Model 99999. Product Usage: Continuous Ventilator The Arkon Anesthesia Delivery System is designed to provide emergency oxygen, vaporized agent delivery and manual ventilation in the event of a power failure scenario. Clinicians are able to use Emergency O2 and manually ventilate the patient, providing gas and agent. However, the anesthesiologist will not have access to mechanical ventilation or ventilator monitoring.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·March 22, 2017

    Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room. Absorber Adapter Assembly Service Kit, part number: 050-9045-00. Absorber Adapter Assembly, part number: 650-1648-01. Arkon Absorber Canister Carrier, part number: 380-0916-01.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·May 24, 2017

    Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs Healthcare Blease 700/900 Series Ventilators. Designed specifically for the mechanical ventilation of adult and pediatric patients under general anesthesia.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·April 29, 2015