109 results
·
16ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·December 19, 2012
DataCare POC is an information management system that provides data management functionality for managing point-of -care testing data.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·December 19, 2012
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.
FDA Enforcement
Class II
·Ongoing·Augustine Temperature Management, LLC·December 25, 2024
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.
FDA Enforcement
Class II
·Completed·Augustine Temperature Management, LLC·January 22, 2025
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.
FDA Enforcement
Class II
·Ongoing·Augustine Temperature Management, LLC·December 25, 2024
Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016
FDA Enforcement
Class II
·Terminated·Roche Diabetes Care, Inc.·November 23, 2016
Fluid Management Set. Catalog Number K08-MP5159A
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·November 30, 2016
Waste Management Kit. Catalog Number K10-04381AP
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·November 30, 2016
DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·December 19, 2012
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; 3) WC77V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.
FDA Enforcement
Class II
·Completed·Augustine Temperature Management, LLC·January 22, 2025
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC71V; 2) WC71V-DEMO; 3) WC71V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.
FDA Enforcement
Class II
·Completed·Augustine Temperature Management, LLC·January 22, 2025
Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department's clinical and business information.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc. Oncology Systems·August 15, 2012
The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in-vitro determinations using a wide variety of tests.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·December 19, 2012
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.
FDA Enforcement
Class II
·Completed·Augustine Temperature Management, LLC·January 22, 2025
IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase¿ BAP Assay (IDS-iSYS BAP) is intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum or plasma on the IDS-iSYS Multi- Discipline Automated Analyser (Analyser). Results are to be used in conjunction with other clinical and laboratory data to aid the clinician in the management of post menopausal osteoporosis and Pagets disease.
FDA Enforcement
Class II
·Terminated·Immunodiagnostics Systems Ltd·October 17, 2012
Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ TaqMan¿ analyzer, COBAS¿ TaqMan¿ 48 analyzer, COBAS¿ AMPLICOR¿ analyzer, and Cobas p 630 instrument for sample preparation, amplification and detection of PCR (Polymerase Chain Reaction) molecular diagnostic analytes.
FDA Enforcement
Class II
·Terminated·Roche Molecular Systems, Inc.·December 19, 2012
Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies. This product is used to alert caregivers when a patient at risk for falls is leaving a bed or chair.
FDA Enforcement
Class II
·Terminated·RF Technologies, Inc.·July 3, 2013
Pain Management Tray. Product Catalog Number: 560602. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
FDA Enforcement
Class II
·Terminated·B. Braun Medical, Inc.·February 21, 2018
Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare Informatics, Inc. Foster City, CA IntelliSpace PACS are image management systems intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RE, RT, MG, SC, VL, as well as hospital/radiology information systems.
FDA Enforcement
Class II
·Terminated·Philips Healthcare Informatics, Inc.·November 20, 2013
Carestream Vue PACS; UPG MX-O SVR 75K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
FDA Enforcement
Class II
·Terminated·Carestream Health Inc.·November 20, 2013