BEUDAMED
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    Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

    FDA Enforcement
    Class II ·Terminated·NOX MEDICAL·October 13, 2021

    Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na+ K+, iCa2+ (ISE), hematocrit (Hct), metabolites (Gluc, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHB, COHB, MetHb), and oxygen saturation (SO2). In addition, the cobas b 123 POC system calculates derived parameters. It is dedicated for use in a Point-of-Care environment and laboratory.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·December 19, 2012

    ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.

    FDA Enforcement
    Class II ·Terminated·Radiometer Medical ApS·July 8, 2020

    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

    ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.

    FDA Recall
    Terminated ·Radiometer Medical ApS Akandevej 21 Bronshoj Denmark·Product code CHL·May 11, 2020

    Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

    FDA Recall
    Terminated ·NOX MEDICAL Keldnaholt Reykjavik Iceland·Product code MNR·September 7, 2021

    STA Heparin Control kit used on STA analyzers (STA, STA Compact, STAR). The STA heparin control kit is a set of two plasmas containing different levels of unfractionated heparin (UFH) intended for the quality control of UFH assays performed on STA analyzers. Each kit contains 6 x 1 mL vials of Reagent 1 (STA Heparin Control 2) and 6 x 1 mL of Reagent 2 (STA Heparin Control 5) packaged in a white cardboard unit container. Distributed in the USA by : Diagnostica Stago, Inc, Five Century Drive, Parsippany, NJ 07054, Lot 02019***.

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code JOX·December 20, 2002

    EE- Series Video Naso Pharyngo Laryngo Scope, VNL-1570STK. Intended to provide optical visualization (via a video monitor) of the Upper Airway.

    FDA Recall
    Terminated ·Pentax Medical Company·Product code EOX·September 30, 2011

    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 Recall
    Terminated ·EKOS Corporation·Product code FOX·August 22, 2016

    Rotating IV Pole Rotating IV Pole falls under the category classified as capital equipment, an optional accessory that may be purchased to facilitate attachment and consolidation of patient equipment to one central patient care area. Devices commonly attached to IV poles include IV pumps, feeding pumps, and infusion fluid bags. Products used on: Giraffe OmniBed, Giraffe Warmers, Panda Warmers and Giraffe Incubators and Giraffe Shuttle. The IV pole also can be mounted to the Care Plus Incubator and Panda IWS.

    FDA Recall
    Terminated ·Ohmeda Medical·Product code FOX·December 1, 2017

    Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection Device, Specimen Jar with preservative. Item code CYTO-KIT-R Gastroenterology: Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. Currently the device is only available for clinical studies.

    FDA Recall
    Terminated ·Covidien, LLC·Product code EOX·June 6, 2016

    BF-XP60 OES Bronchofiberscope, Model No. BF-XP60

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code EOX·August 16, 2021

    Covidien Cytosponge Cell Collection Device. Item code CYTO-101-01. Gastroenterology: -.Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. This device is currently only being used in clinical studies.

    FDA Recall
    Terminated ·Covidien, LLC·Product code EOX·June 6, 2016

    IVEA 500A Intended for Med-Surg patient care.

    FDA Recall
    Terminated ·Firefly Medical, Inc.·Product code FOX·November 1, 2016

    IVEA Product Part Number 16100 Model 500A

    FDA Recall
    Terminated ·Firefly Medical, Inc.·Product code FOX·August 24, 2017

    Medtronic HMS PLUS, Hemostasis Management System, Model 30514. It is a microprocessor based, multichannel clot timing instrument with automated syringe handling for pipetting blood into single use cartridges. It performs in vitro heparin sensitivity evaluations, heparin assays, activated clotting times and platelet function evaluations.

    FDA Recall
    Terminated ·Medtronic Inc·Product code JOX·December 14, 2009

    EE- Series Video Esophagoscopes, EE-1580K. Intended to provide optical visualization of (via a video monitor) and therapeutic access to, the Upper Gastrointestinal Track.

    FDA Recall
    Terminated ·Pentax Medical Company·Product code EOX·September 30, 2011

    Two-stage and three-stage I.V. poles are shipped as an optional accessory to a bed or stretcher. The I.V. poles are stationary, height adjustable stands intended to hold infusion liquids, infusion accessories, and/or other medical devices. They may be used on the following parent devices: Model 2030 (EPIC II), model 3005 S3 beds and stretcher. models 1105, 1105E, 1105X, 1105XE, 1115, 1115E, 1115X, 1115XE, 1125E, 1125X and 1125XE.

    FDA Recall
    Terminated ·Stryker Medical Division of Stryker Corporation·Product code FOX·October 13, 2015

    BioTek Gen5CL Microplate Data Collection and Analysis Software. Intended for clinical lab use with ELx800 and ELx808 microplate readers, offers preprogrammed clinical diagnostic assays within a PC-based application.

    FDA Recall
    Terminated ·BioTek Instruments, Inc. Highland Park/Box·Product code JJQ·March 12, 2009

    Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na+ K+, iCa2+ (ISE), hematocrit (Hct), metabolites (Gluc, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHB, COHB, MetHb), and oxygen saturation (SO2). In addition, the cobas b 123 POC system calculates derived parameters. It is dedicated for use in a Point-of-Care environment and laboratory.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code CHL·November 14, 2012