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    QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223

    FDA Enforcement
    Class II ·Terminated·Qiagen Sciences LLC·January 12, 2022

    Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments. Software utilized in multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments.

    FDA Enforcement
    Class II ·Terminated·Phadia US Inc·January 21, 2015

    Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine. Material #11515088

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·August 2, 2023

    Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images may only be interpreted using an FDA approved monitor that offers at least 5 M pixel resolution and meets other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians an assistants.

    FDA Enforcement
    Class II ·Terminated·Ge Healthcare It·November 6, 2013

    Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·July 3, 2019

    Imagecast PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image and interpretations. Mammongraphic may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA.

    FDA Enforcement
    Class II ·Terminated·Ge Healthcare It·January 22, 2014

    Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software Version: Software version 3.2.0.1 Product Description: Welch Allyn Spot Vision Screener VS100, FDA product code name: Refractometer, ophthalmic One unit per package

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·March 25, 2026

    Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: No, not a component

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, INc.·January 29, 2025

    Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: no, not a component

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, INc.·January 29, 2025

    Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: No, not a component

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, INc.·January 29, 2025

    Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA.

    FDA Enforcement
    Class II ·Terminated·Ge Healthcare It·August 3, 2016

    Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·June 13, 2018

    Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·June 13, 2018

    Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It has been assigned the product code FSO by the FDA and is classified as a Class I medical device. Intended for improving the visibility of objects through magnification and illumination.

    FDA Enforcement
    Class II ·Terminated·Leica Microsystems, Inc.·April 27, 2016

    LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878

    FDA Enforcement
    Class II ·Terminated·Zest Anchors LLC·February 12, 2014

    Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005, 686F030007, 686G030002, and 686G030102. Intended for use with adults, pediatrics and neonates and is intended to provide infusions of parenteral fluids/medications, blood and blood products indicated for infusion through FDA approved routes of administration.

    FDA Enforcement
    Class I ·Terminated·B. Braun Medical, Inc.·July 25, 2012

    CaviWipes1 Extra Large, Part No. 13-5150 The brand name of the device is CaviWipes1 Extra Large, a surface disinfectant. The device has been assigned the product code LRJ (General Purpose Disinfectant) by the FDA and is classified as a Class I Medical Device. CaviWipes1 Extra Large is intended to be used to disinfect surfaces.

    FDA Enforcement
    Class II ·Terminated·Metrex Research, LLC.·March 15, 2017

    QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organisms, including the SARS-CoV-2 virus, in nasopharyngeal swabs (NPS) eluted in universal transport media collected from patients suspected of COVID-19 by their healthcare provider.

    FDA Enforcement
    Class II ·Terminated·Qiagen Sciences LLC·September 16, 2020

    Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.

    FDA Enforcement
    Class II ·Terminated·Neuro Kinetics, Inc.·September 9, 2015

    Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.

    FDA Enforcement
    Class II ·Terminated·Medtronic Sofamor Danek USA, Inc·April 28, 2021