BEUDAMED
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    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

    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

    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

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

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

    Product is an EO Sterile, Polydioxanone Violet monofilament synthetic absorbable surgical suture with needle, size 3/0 (2.0 Metric), NFS-2, 19 mm Needle. Product is sealed inside an inner foil pouch with an outside tyvek pouch. The outer tyvek pouch has the defective seal. No suture is exposed or visible through the foil wrap which must be torn to have access to the suture and needle. Product is boxed (12 to a box) and shrink wrapped. Product is labeled STERILE. Box Label includes: '3/0 (2.0 metric) MONO-DOX Violet Monofilament Polydioxanone Suture USP M398A CP-B-M398A-04 Rx Only NFS-2 19 mm 3/8 CUTTING Manufactured by: CP Medical Portland, OR USA 30' (75 cm) One Dozen Sterile Synthetic Absorbable Suture '. Packet Label includes: '3/0 (2.0 metric) 398 NFS-2 19mm 3/8 CUTTING 30' (75cm) POLYDIOXANONE Violet (PDO) Monofilament Synthetic Absorbable Suture STERILE EO Manufacturer: CP Medical Portland, OR USA' . Product is also distributed under three private labels, Webster Veterinary, Butler, and Phoenix Pharmaceutical, Inc. Webster Veterinary Box Label includes: '3/0 (2.0 metric) WEBMAX Violet Monofilament Polydioxanone Suture Distributed by: WEBSTER VETERINARY 07-836-4288(M398A) 26-BM398A-01 Vet Use Only CUTTING NFS-2 30' (75 cm) 3/8 19mm'. Webster Veterinary Packet Label includes: '3/0 (2.0 metric) 07-836-4288(M398A) WEBMAX Violet Monofilament Polydioxanone Absorbable Sterile Suture 30' (75cm) Vet Use Only Distributed by: Webster Veterinary Supply, Inc. CUTTING NFS-2 3/8 19mm 26-SM398A-01'. Butler Box label includes: 'Butler 3/0 (2.0 metric) MONOSORB Violet Monofilament Polydioxanone Suture 029254 Vet Use Only NFS-2 CUTTING 30' (75 cm) 3/8 19mm 01-BM398A-02 SUTUREVET'. Butler Packet Label includes: '3/0 (2.0 metric) NFS-2 19mm 3/8 CUTTING 30' (75cm) 029254 MONOSORB Violet Monofilament Prolydioxanone Synthetic Absorbable Suture STERILE EO Distributed Exclusively by: Butler Animal Health Supply'. Phoenix Pharmaceutical Box label includes: '3/0 (2.0 metric) 0398 Poly-Dox Sutures VIOLET MONOFILAMENT (Polydioxanone) Suture Sterile Synthetic Absorbable Suture 30' (75cm) Vet Use Only Cutting PFS-2 3/8 19mm Distributed By: PHOENIX PHARMACEUTICAL, INC.'. Phoenix Pharmaceutical Packet label includes: '3/0 (2.0 metric) 0398 Poly-Dox Sutures VIOLET MONOFILAMENT (Polydioxanone) Suture 30' (75cm) Sterile, Synthetic Absorbable Suture Veterinary Use Only Cutting PFS-2 3/8 19mm Distributed By: PHOENIX PHARMACEUTICAL, INC.'.

    FDA Recall
    Terminated ·C P Medical·Product code GAM·April 3, 2007

    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

    steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.

    FDA Enforcement
    Class II ·Terminated·EOS Imaging·January 1, 2014

    ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96 S, EOS Imaging Catalogue Number 9000111773; and MOBELI Dual Grip Grab Handle, ROTH Catalogue Number 14002 25 S, EOS Imaging Catalogue Number 9000111774.

    FDA Enforcement
    Class II ·Terminated·EOS Imaging·July 5, 2017

    EOS System X- ray beam Digital radiography system used in general radiographic examinations.

    FDA Enforcement
    Class II ·Terminated·EOS Imaging·January 15, 2014

    sterEOS workstation

    FDA Enforcement
    Class II ·Terminated·EOS Imaging·September 26, 2018

    The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose. The scan length is defined by the user and may cover the whole body or a specific area (spine, lower limbs, etc.). EOSedge consists of a gantry and an acquisition workstation. ¿ The gantry contains two orthogonal acquisition units, each of which comprises an X-ray source (high frequency generator + X-ray tube + collimator) and an X-ray detection system (detector + electronics). ¿ The acquisition workstation and its software control the generators and detectors. It is also used to enter patient data, via RIS/HIS or manually, to define acquisition parameters, process images and record images in DICOM 3.0 format. The intended use/indications for use, technological characteristics, and principles of operation of the EOSedge system are described below.

    FDA Enforcement
    Class II ·Terminated·EOS Imaging·April 21, 2021

    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

    First Responder Kit containing a 240-liter aluminum oxygen cylinder with individually packaged regulator, cannula, and bag mask resuscitator, all packaged in a shipping container labeled as: Product #L903, Desc FIRST RESPONDER KIT, Catalog #L903. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.

    FDA Recall
    Terminated ·Allied Healthcare Products Inc·Product code ECX·May 15, 2009

    Empty D aluminum oxygen cylinders packaged in shipping containers labeled as: Product #0022-44P, CYL 02 ALUM 400 LITER, Catalog #31-10-0014. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.

    FDA Recall
    Terminated ·Allied Healthcare Products Inc·Product code ECX·May 15, 2009

    Empty M9 aluminum oxygen cylinders packaged in shipping containers (1 per container) labeled as: Product #0022-57P, Desc: CYL 02 ALUM 240 LITER, Catalog #31-10-2012. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.

    FDA Recall
    Terminated ·Allied Healthcare Products Inc·Product code ECX·May 15, 2009

    Empty Jumbo D aluminum oxygen cylinders packaged in shipping containers labeled as: Product #0022-96P, Desc CYL 02, JUMBO D, W/TYPE B POST, Catalog #31-10-2017. The brand and firm name on the label affixed to the cylinder is Chemetron, Allied Healthcare Products Inc., St. Louis, MO.

    FDA Recall
    Terminated ·Allied Healthcare Products Inc·Product code ECX·May 15, 2009

    Grab n Go Opti series VIPR system Model # PRX-9615 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.

    FDA Recall
    Terminated ·Western Scott Fetzer Company·Product code ECX·August 15, 2019

    Grab n Go Opti series VIPR system Model # PRX-9646 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.

    FDA Recall
    Terminated ·Western Scott Fetzer Company·Product code ECX·August 15, 2019