20 results
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142ms
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Sources: EU EUDAMED, US FDA
INTELLIGENCE IN MEDICAL TECHNOLOGIES
FDA registration
INTELLIGENCE IN MEDICAL TECHNOLOGIES·1 product·🇫🇷 France
AEYE-DS RETINA SCREENING
FDA Adverse Event
Injury
·AEYE HEALTH INC.·Product code PIB·January 22, 2025
REAL INTELLIGENCE ROBOTIC DRILL
FDA Adverse Event
Injury
·BLUE BELT TECHNOLOGIES·Product code OLO·July 25, 2022
TRUDI¿ NAVIGATION SYSTEM
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code PGW·April 3, 2024
Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System, analyzer, chemistry (photometric, discrete), for clinical use Product Usage: The Siemens Healthcare Diagnostics Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensor technology for clinical use.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JJE·March 3, 2017
INSPIRE
FDA Adverse Event
Injury
·INSPIRE MEDICAL SYSTEMS INC·Product code MNQ·July 17, 2025
INSPIRE
FDA Adverse Event
Injury
·INSPIRE MEDICAL SYSTEMS INC·Product code MNQ·July 17, 2025
Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensor technology for clinical use
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc.·Product code JJE·March 24, 2016
Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensor technology for clinical use
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc.·Product code JJE·March 24, 2016
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
FDA Recall
Open, Classified
·Blue Belt Technologies, Inc·Product code OLO·September 7, 2023
Sungo Cert GmbH
Authorized representative
🇩🇪 Germany·173 Manufacturers·3269 Devices
MedNet EC-REP GmbH
Authorized representative
🇩🇪 Germany·464 Manufacturers·5263 Devices
Lotus NL B.V.
Authorized representative
🇳🇱 Netherlands·584 Manufacturers·21427 Devices
Advena Limited
Authorized representative
🇲🇹 Malta·467 Manufacturers·13717 Devices
Eunitor GmbH
Authorized representative
🇩🇪 Germany·83 Manufacturers·896 Devices
RIOMAVIX LTD
Authorized representative
🇪🇸 Spain·400 Manufacturers·4531 Devices
SUNGO Europe B.V.
Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices
Shanghai International Holding Corp. GmbH(Europe)
Authorized representative
🇩🇪 Germany·637 Manufacturers·33064 Devices
MedEnvoy Global BV
Authorized representative
🇳🇱 Netherlands·143 Manufacturers·2306 Devices
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices