BEUDAMED
    20 results · 15ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.

    FDA Enforcement
    Class II ·Terminated·Mckesson Medical Immaging·August 6, 2014

    Horizon Medical Imaging, Picture Archive Communication System (PACS).

    FDA Enforcement
    Class II ·Terminated·Mckesson Information Solutions LLC·February 19, 2014

    Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application that is intended to receive transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.

    FDA Enforcement
    Class II ·Terminated·Mckesson Medical Immaging·June 18, 2014

    McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from medical imaging systems.

    FDA Enforcement
    Class II ·Terminated·Mckesson Information Solutions LLC·October 9, 2013

    McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1.

    FDA Enforcement
    Class II ·Terminated·Mckesson Medical Immaging·March 23, 2016

    Minor Surgical Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573208 7519-DHCG MINOR KIT 573210 7581-CSD Minor KIT 573741 7667-HMI Minor Kit 31144507 7519 Minor Surgical Kit 573830D MINOR KIT

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·July 29, 2015

    MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular, LLC·April 24, 2013

    Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical image systems. The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammographic images). Horizon Medical Imaging is intended to function with a variety of storage systems and printers via DICOM and other computer industry standard interfaces and protocols. Horizon Medical Imaging is indicated for use by trained medical professionals including, but not limited to, radiologist, physicians, and medical technologists. Horizon Medical Imaging is also indicated for use in soft copy diagnostic interpretation of medical images and video by physicians trained in such practice (specifically including soft copy diagnostic interpretation of mammographic images).

    FDA Enforcement
    Class II ·Terminated·Mckesson Medical Imaging Group·August 29, 2012

    MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany. Cardiopulmonary support system.

    FDA Enforcement
    Class II ·Terminated·Maquet Medical Systems USA·November 6, 2013

    Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·November 16, 2016

    Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·November 16, 2016

    Ami HTX.

    FDA Enforcement
    Class II ·Ongoing·Spectral Instruments Inc·June 25, 2025

    Am I Pregnant? One Step HCG Pregnancy Test REF 100-17

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product was distributed for both the AP Large and AP Standard sizes. The LAP-BAND System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions.

    FDA Enforcement
    Class II ·Terminated·Apollo Endosurgery Inc·October 8, 2014

    BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451. AortaScan AMI 9700, Model Numbers: 0270-0636, 0270-0639, and U270-0636.

    FDA Enforcement
    Class II ·Terminated·Verathon, Inc.·March 16, 2016

    Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·December 24, 2014

    Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods on the Dimension Vista System.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·March 5, 2014

    Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI).

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics Inc·August 7, 2019

    ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No. RSM110 product Usage: The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2 and one or more obesityrelated comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.

    FDA Enforcement
    Class II ·Terminated·Reshape Medical Inc·November 16, 2016

    ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. 01-0013-001 The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2 and one or more obesity related comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.

    FDA Enforcement
    Class II ·Terminated·Reshape Medical Inc·August 24, 2016