ClearanceBrief
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)
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Top companies in OUG

DateFirm and productCodeLinked 510(k)
Apr 17, 2023Radiometer 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
OUGNone listed
Mar 2, 2023Biomerieux 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
OUGNone listed
Sep 2, 2021BioMerieux SA
MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
Terminated
OUGNone listed
Oct 23, 2020Pentax of America Inc
9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal
Terminated
OUGNone listed
Oct 23, 2020Pentax of America Inc
9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
Terminated
OUGNone listed
Jan 17, 2020Beckman 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
OUGNone listed
Sep 25, 2019ENDOTRONIX
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
OUGNone listed
Aug 8, 2019Radiometer 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
OUGNone listed
May 20, 2019Opternative 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
OUGNone listed
Dec 6, 2017Intel-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
OUGNone listed
Dec 27, 2016Philips 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
OUGNone listed
Dec 15, 2016Beckman 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
OUGNone listed
Apr 4, 2016Merge Healthcare, Inc.
Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
Terminated
OUGNone listed
Feb 19, 2016Medtronic 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
OUGNone listed
Feb 11, 2016Beckman 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
OUGNone listed
Jan 30, 2016Merge 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
OUGNone listed
Sep 23, 2015Beckman 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
OUGNone listed
Jan 16, 2015Maquet 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
OUGNone listed
Dec 23, 2014Horiba 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
OUGNone listed
May 21, 2014Philips 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
OUGNone listed
Sep 25, 2013Maquet 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
OUGNone listed
May 22, 2013Medical 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
OUGNone listed
Jul 5, 2012Philips 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
OUGNone listed
Jan 13, 2012CareFusion 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
OUGNone listed

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