BEUDAMED
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    Bausch & Lomb Stellaris Vision Enhancement System.

    FDA Recall
    Terminated ·Bausch & Lomb Inc·Product code NFJ·January 15, 2010

    Bausch & Lomb Millennium Microsurgical System.

    FDA Recall
    Terminated ·Bausch & Lomb Inc·Product code NFJ·January 15, 2010

    CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179

    FDA Recall
    Terminated ·Diagnos Inc·Product code NFJ·January 11, 2022

    EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).

    FDA Recall
    Terminated ·Haag-Streit USA Inc·Product code NFJ·January 5, 2017

    Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code NFJ·April 4, 2016

    Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicated for acquiring, displaying and storing image data from KOWA s mydriatic and non-mydriatic ophthalmic cameras.

    FDA Recall
    Terminated ·Kowa Optimed Inc·Product code NFJ·November 3, 2020

    FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive Format). Catalog numbers: 000000-20107-750 (DVD with either FORUM v 3.1 or v 3.1.1) 000000-2058-601 (DVD with either FORUM v 3.2 or 3.2.1); 000000-2084-928 (USB drive with FORUM 3.2.1) Ophthalmic image management system.

    FDA Recall
    Terminated ·Carl Zeiss Meditec AG Carl Zeiss Promenade 10 Jena Germany·Product code NFJ·January 22, 2015

    Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. Merge Eye Care PACS is a software solution using databases for patient demographics, server and other systems of intercommunication with hospital systems via HL7 and DICOM to provide to clinicians a single image viewing and management solution of images imported from various contributing devices throughout the clinical environment. Merge Eye Care PACS provides the ability to review data from any network-connected computer, and is protected by appropriate security login which permits only authorized user access. Symphony uses 256 bit or greater encryption via secure socket layer (SSL) to assure a network environment which is secure.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code NFJ·June 13, 2017

    Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code NFJ·March 28, 2016

    Merge Eye Station and Merge Eye Care PACS.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code NFJ·April 4, 2016

    IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices without controlling or altering the functions and parameters of any medical devices or through computerized networks.

    FDA Recall
    Terminated ·Topcon Medical Systems, Inc.·Product code NFJ·March 6, 2019

    Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended to be used by trained healthcare professionals and clinicians to access archived multimedia data, forms and patient information.

    FDA Recall
    Terminated ·Topcon Medical Systems, Inc.·Product code NFJ·December 18, 2020

    Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekta Harmony; c. Elekta Synergy; d. Elekta Infinity; e. Versa HD

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·October 20, 2021

    Alkaline Phosphatase Substrate Mfg. for Alfa Wassermann Diagnostic Technologies LLC, Caldwell, N.J. in 2.1 mL and 7.5mL containers. In vitro diagnostic.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CJE·June 9, 2006

    Alkaline Phosphatase Buffer Mfg. for Alfa Wassermann Diagnostic Technologies LLC, Caldwell, N.J. in 8.4 mL and 30 mL containers. In vitro diagnostic.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CJE·June 9, 2006

    ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a ''Stapler, reload, TR35W, TR776, TCR 75, TCR 55, TRT75,

    FDA Recall
    Terminated ·International Surgical Supply, Inc.·Product code KDC·September 3, 2003

    ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Stapler EMS Endo Hernia , item # 8034.

    FDA Recall
    Terminated ·International Surgical Supply, Inc.·Product code KDC·September 3, 2003

    ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Thoracic Trocar Sleeve, rounded tip, Item # TT012.

    FDA Recall
    Terminated ·International Surgical Supply, Inc.·Product code KDC·September 3, 2003

    ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Stapler, Articulating, Linear, item # AX55

    FDA Recall
    Terminated ·International Surgical Supply, Inc.·Product code KDC·September 3, 2003

    ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Cutter, ETS Endoscopic Linear, 35 mm, item # TSB 35.

    FDA Recall
    Terminated ·International Surgical Supply, Inc.·Product code KDC·September 3, 2003