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

    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

    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

    Part #: SAM XT-C, Model: Hi-Viz Orange or Civilian

    FDA Recall
    Terminated ·The Seaberg Company Inc·Product code GAX·May 2, 2018

    CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code GAX·August 5, 2014

    Part #: SAM XT-M, Model: Tactical Black or Military

    FDA Recall
    Terminated ·The Seaberg Company Inc·Product code GAX·May 2, 2018

    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

    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 Recall
    Terminated ·Mar-Med Co·Product code GAX·December 28, 2020

    IVEA 500A Intended for Med-Surg patient care.

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

    Cap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code GAX·August 5, 2014

    IVEA Product Part Number 16100 Model 500A

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

    Part #: SAM XT-C, Model: Hi-Viz Blue

    FDA Recall
    Terminated ·The Seaberg Company Inc·Product code GAX·May 2, 2018

    MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet, Catalog number MATC; UPC 78353 00010; MATResponder Tourniquet and MATCombat Tourniquet are essentially the same product with different color schemes manual nonpneumatic tourniquet devices. The device provides for emergency blood flow occlusion to the limbs

    FDA Recall
    Terminated ·Pyng Medical Corporation 210-13480 Crestwood Pl Richmond Canada·Product code GAX·August 31, 2015

    Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code GAX·August 5, 2014

    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