Panels › General Hospital › Product code OUG · Class 1
Medical Device Data System
Regulation 880.6310
0510(k)s in 12 months (1 all time)
0recalls in 12 months (24 all time)
0recalls that name a 510(k)
Top companies in OUG
| Company | 510(k)s | Recalls |
|---|---|---|
| Beckman Coulter Inc. | 0 | 4 |
| BioMerieux SA | 0 | 2 |
| Merge Healthcare, Inc. | 0 | 2 |
| Pentax of America Inc | 0 | 2 |
| Radiometer Medical ApS | 0 | 2 |
| CareFusion 209 Inc. | 0 | 1 |
| ENDOTRONIX | 0 | 1 |
| Horiba Instruments Inc | 0 | 1 |
| Intel-GE Care Innovations LLC | 0 | 1 |
| Maquet Cardiovascular Us Sales, Llc | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2023 | Radiometer Medical ApS AQURE REF 933-599
Software Versions
2.5.2
2.5.3
2.5.4
2.6.0
2.6.1
The AQURE system is intended to let you manage analytical devices and operator profiles.
The user can associate patient data with tes Open, Classified |
OUG | None listed |
| Mar 2, 2023 | Biomerieux Inc MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture activities and the laboratory information system (L Open, Classified |
OUG | None listed |
| Sep 2, 2021 | BioMerieux SA MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System Terminated |
OUG | None listed |
| Oct 23, 2020 | Pentax of America Inc 9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal Terminated |
OUG | None listed |
| Oct 23, 2020 | Pentax of America Inc 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal), Terminated |
OUG | None listed |
| Jan 17, 2020 | Beckman Coulter Inc. LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identificat Terminated |
OUG | None listed |
| Sep 25, 2019 | ENDOTRONIX myCordella Patient Kit without ECG, The Cordella System is a comprehensive at-home heart failure management platform that provides the clinician tools to monitor the progression of heart failure. Terminated |
OUG | None listed |
| Aug 8, 2019 | Radiometer Medical ApS AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999
Intended use: The AQURE system is intended to let you manage analytical devices and operator p Terminated |
OUG | None listed |
| May 20, 2019 | Opternative Inc The Visibly Online Refractive Vision Test which is part of the Visibly Vision Test Solution, This is a software application that partners and their customers were given access to. Product Usage: This Open, Classified |
OUG | None listed |
| Dec 6, 2017 | Intel-GE Care Innovations LLC Health Harmony Mobile application software
Product Usage:
Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patie Terminated |
OUG | None listed |
| Dec 27, 2016 | Philips Electronics North America Corporation Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with IntelliVue Information Center iX or Classic Information Center Terminated |
OUG | None listed |
| Dec 15, 2016 | Beckman Coulter Inc. MicroScan LabPro Data Management System.
Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manual Terminated |
OUG | None listed |
| Apr 4, 2016 | Merge Healthcare, Inc. Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare. Terminated |
OUG | None listed |
| Feb 19, 2016 | Medtronic MiniMed Inc. CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuous glucose information Terminated |
OUG | None listed |
| Feb 11, 2016 | Beckman Coulter Inc. MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41
Catalog No. 10638819, 10638820, 10638823, 10638824, 10638825,10638826, 10714149,10714159, 10805072, 10805073, 10975000, 1097 Terminated |
OUG | None listed |
| Jan 30, 2016 | Merge Healthcare, Inc. Merge FlexConnect software, a component of Merge LIS.
Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applications Terminated |
OUG | None listed |
| Sep 23, 2015 | Beckman Coulter Inc. MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 10714149, 10714150. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility t Terminated |
OUG | None listed |
| Jan 16, 2015 | Maquet Medical Systems USA TEGRIS System manufactured by MAQUET GMBH in Germany
The Maquet Tegris OR Integration System is designed to be used as the central operating unit in an operating room. The integration system has two m Terminated |
OUG | None listed |
| Dec 23, 2014 | Horiba Instruments Inc Lite DM (Lite Data Manager)
Software Version(s): Versions 2.0.0.19 and lower
Product Model #: D00A00224D
The Lite DM (Lite Data Manager) is a software application developed by HORIBA
Medical intended Terminated |
OUG | None listed |
| May 21, 2014 | Philips Healthcare Informatics, Inc. Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50
XIRIS is a radiology information system (RIS) is a computer system that assist radiology services in the storing, manipul Terminated |
OUG | None listed |
| Sep 25, 2013 | Maquet Cardiovascular Us Sales, Llc TEGRIS system
Four labels of the Tegris System include:
Emergency button (1703.72)
MAQUET GmbH & Co. KG
Kehler-Strabe 31
Baden-Wuerttemberg
76437 Rastatt, Germany
Touch screen (elo)
Elo TouchSy Terminated |
OUG | None listed |
| May 22, 2013 | Medical Information Technology, Inc. MEDITECH Bi-Directional interactive Communication Analyzer Interface;
Integrates with MEDITECH's Laboratory Information System (LIS) with Other Vendor systems to manage the transfer of patient resul Terminated |
OUG | None listed |
| Jul 5, 2012 | Philips Healthcare Inc. Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange.
Philips Xcelera Connect R2.x is a generic interface and data mapping engine between a Hospital Information Syst Terminated |
OUG | None listed |
| Jan 13, 2012 | CareFusion 209 Inc. NicVue Software version 2.9.2 and 3.0.1.
Medical Device Data System (MDDS) Intended use: The NicVue software is intended to be the patient database for various Nicolet applications. The NicVue softw Terminated |
OUG | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.