BEUDAMED
    25 results · 18ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·August 17, 2016

    I-View¿ Contrast Enhanced Digital Mammography, ASY-08109

    FDA Enforcement
    Class II ·Terminated·Hologic, Inc.·January 2, 2019

    Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use

    FDA Enforcement
    Class II ·Terminated·Hologic, Inc·October 25, 2017

    Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.

    FDA Enforcement
    Class II ·Terminated·Hologic, Inc.·June 11, 2014

    NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Number: RFC2009 Product Usage: The NovaSure Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in premenopausal women with mehorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.

    FDA Enforcement
    Class II ·Terminated·Hologic, Inc·March 5, 2014

    Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.

    FDA Enforcement
    Class II ·Terminated·Hologic, Inc·September 28, 2016

    SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece)

    FDA Enforcement
    Class II ·Terminated·Hologic, Inc·September 14, 2016

    SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for ATEC0914-12MR Handpiece Product Usage: The Sure Sight Obturator Introducer Localization System (ILS-OB) is a Hologic accessory kit. It is sold as an independent product for use with the ATEC MRI hand pieces. This sterile accessory kit is available in two lengths, is sold only in the US and has a 6 month shelf life. It contains a single use introducer stylet, introducer sheath, needle guide and localizing obturator

    FDA Enforcement
    Class II ·Terminated·Hologic, Inc·September 14, 2016

    Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.

    FDA Enforcement
    Class II ·Terminated·Hologic, Inc.·May 22, 2013

    Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. The Selenia Full Field Digital Mammography System is intended for use in the same clinical applications as traditional screen-film mammography systems. Mammography images can be interpreted on either hard copy film or soft copy review workstations, cleared for mammography

    FDA Enforcement
    Class II ·Terminated·Hologic, Inc.·October 9, 2013

    Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.

    FDA Enforcement
    Class II ·Terminated·Hologic, Inc.·May 22, 2013

    Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.

    FDA Enforcement
    Class II ·Terminated·Hologic, Inc.·June 11, 2014

    Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument is a fully automated sample-to-result instrument, eliminating the need for batch processing and automates all aspects of nucleic acid testing on a single, integrated platform. The Panther can be test samples with random access or batch managed; can perform multiple assays on the same patient sample with up to 4 different assays simultaneously.

    FDA Enforcement
    Class II ·Terminated·Hologic, Inc·February 21, 2018

    Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.

    FDA Enforcement
    Class II ·Terminated·Hologic, Inc.·October 3, 2012

    Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.

    FDA Enforcement
    Class II ·Terminated·Hologic, Inc.·October 3, 2012

    Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.

    FDA Enforcement
    Class II ·Terminated·Hologic, Inc·May 4, 2016

    ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister used to collect fluid during a breast biopsy.

    FDA Enforcement
    Class II ·Terminated·Hologic, Inc·July 27, 2016

    SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine sound

    FDA Enforcement
    Class II ·Terminated·Hologic, Inc·November 30, 2016

    CF InPlex ASR Card; Catalog Number: 95-0501.

    FDA Enforcement
    Class II ·Terminated·Hologic, Inc·May 4, 2016

    Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.

    FDA Enforcement
    Class II ·Terminated·Hologic, Inc·August 9, 2017