BEUDAMED
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    Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays . Sofia 2 is intended for professional and laboratory use.

    FDA Recall
    Terminated ·Quidel Corporation·Product code PSZ·December 15, 2017

    BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code PSZ·April 3, 2019

    BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Catalog Number: 256055

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code PSZ·April 3, 2019

    QUIDEL Sofia SARS Antigen FIA IVD REF 20374

    FDA Recall
    Terminated ·Quidel Corporation·Product code PSZ·September 25, 2020

    Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360I, 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures.

    FDA Recall
    Terminated ·PSC Industries Inc·Product code GEI·June 1, 2012

    Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420, 510 (k) #K884175. The surgical device is package one (1) per Tyvek peel pouch with ten (10) Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures

    FDA Recall
    Terminated ·PSC Industries Inc·Product code GEI·June 1, 2012

    Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electrosurgical./Extendable Pencils, 510(k)#K936304, Model Number: 75800. The device is packaged in a sterile Tyvek peel pouch within a cardboard box. The cartons contain 25 pouches per box. Pens/Pencils and Handles -- Olsen Medical Pens/Pencils and handles are designed to hold active electrodes Single Use device intended for coagulating and cutting tissue during surgical procedures.

    FDA Recall
    Terminated ·PSC Industries Inc·Product code GEI·June 5, 2012

    Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360K 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords - Olsen Medical Bipolar Forceps and Cords are intended for use in coagulating tissue during surgical procedures.

    FDA Recall
    Terminated ·PSC Industries Inc·Product code GEI·June 1, 2012

    Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Electrosurgical./Extendable Pencils, 510(k) #K936304, Model Number: 75820. The device is packaged in a sterile Tyvek peel pouch within a cardboard box which contains 24 pouches per box. Pens/Pencils and Handles -- Olsen Medical Pens/Pencils and handles are designed to hold active electrodes Single Use device intended for coagulating and cutting tissue during surgical procedures.

    FDA Recall
    Terminated ·PSC Industries Inc·Product code GEI·June 5, 2012

    Psi Bands acupressure/acustimulation wrist bands in the following colors: Racer Black (UPC 859570001036), Daisy Chain (UPC 859570001029), Color Play (UPC 859570001043) and Cherry Blossom (UPC 859570001012).

    FDA Recall
    Terminated ·Psi Health Solutions·Product code MVV·April 26, 2007

    Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705. The surgical device is package non-sterile into small plastic tubes. Olsen Medical Biopolar Reusable Bayonet Forceps and cords are intended for use in coagulating tissue during surgical procedures.

    FDA Recall
    Terminated ·PSC Industries Inc·Product code GEI·June 1, 2012

    Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipolar Forceps, Model #20-0431, 510 (k) #K072937. Each unit of this sterile surgical device is packaged in a Tyvek peel pouch in boxes which contain five (5)Tyvek peel pouches per box. Bayonet Bipolar Irrigating Forceps are intended for use in electro-surgery for coagulation and irrigation of tissue.

    FDA Recall
    Terminated ·PSC Industries Inc·Product code GEI·June 1, 2012

    Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K885199. The surgical device is package in non-sterile small plastic tubes. Monopolar Reusable Forceps - are intended for use in cutting and coagulating tissue during surgical procedures.

    FDA Recall
    Terminated ·PSC Industries Inc·Product code GEI·June 1, 2012

    GE Datex-Ohmeda Advance Anesthesia Gas-Machine.

    FDA Recall
    Terminated ·GE Healthcare·Product code BSZ·February 5, 2009

    Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilation.

    FDA Recall
    Terminated ·Mindray DS USA, Inc. d.b.a. Mindray North America·Product code BSZ·August 13, 2012

    Newport Portable Package, Model #50000, Serial # 13591, 13592, 13604, 13606, 13614, 13662, 13663, 13664, 13726, 13731, 13733, 13736, 13737, 13738, 13740, 13768, 13770, 13771, 13772, 13784, 13787. Product Usage: Portable Analgesia Gas Machine.

    FDA Recall
    Terminated ·Accutron Inc·Product code BSZ·April 29, 2012

    CM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Conscious Sedation Unit Analgesia Gas Machine.

    FDA Recall
    Terminated ·Accutron Inc·Product code BSZ·April 29, 2012

    GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code BSZ·August 28, 2013

    McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and records data both through manual entry and from monitors which themselves are attached to patients, such as in the operating room environment. The system provides clinical decision support by communicating potential Adverse Drug Event alerts proactively during the pre-anesthesia evaluation and at the point-of-care. The system is generally indicated in the anesthetizing environment when the anesthesia provider decides to perform a patient assessment, to generate a paper and/or electronic record of the administration of anesthesia to a patient, and to document care.

    FDA Recall
    Terminated ·MCKESSON TECHNOLOGIES INC.·Product code BSZ·March 15, 2013

    GE Datex-Ohmeda ADU Carestation Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients.

    FDA Recall
    Terminated ·GE Healthcare·Product code BSZ·October 30, 2008