297 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Coronary Artery Disease Machine Learning-Based Notification Software
FDA classification
FDA Class 2
·Coronary Artery Disease Machine Learning-Based Notification Software
Prismaflex
FDA UDI
GAMBRO AB·07332414105266·The Prismaflex control unit is a software contr...
Cornerstones4Care® Powered by Glooko Mobile Application
FDA UDI
GLOOKO, INC.·00855093008040·Cornerstones4Care® Powered by Glooko Mobile App...
Nonin
FDA UDI
NONIN MEDICAL, INC.·00849686070620·Intermediate Cable
Glooko Mobile Application
FDA UDI
GLOOKO, INC.·00855093008033·The Glooko Mobile application for iOS and Andro...
Modified Instrument - HXX
FDA UDI
Ulrich Medical Usa, Inc.·00810076335070·Self-Retaining SR25 Screwdriver, 10" length
QX WORLD KFT
FDA registration
QX WORLD KFT·2 products·🇭🇺 Hungary
Nexxis OR
FDA UDI
Barco NV·05415334025233·Nexxis Management Suite
QUEX-ED
FDA UDI
QX WORLD LTD·05999860882015·Biofeedback device with software
AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
X-SMART W/CONTRA ANGLE EUR
FDA Adverse Event
Malfunction
·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EGS·February 1, 2022
X-SMART W/CONTRA ANGLE EUR
FDA Adverse Event
Malfunction
·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EKX·March 30, 2023
X-SMART PLUS
FDA Adverse Event
Malfunction
·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EGS·January 24, 2023
KALIX II IMPLANT, MODEL 141 0XX WITH XX
FDA 510(k)
FDA Class 2
·Orthopedic
DDU-1XX Series Battery Pack
FDA UDI
DEFIBTECH, L.L.C.·00815098020362·
DDU-1XX Series Battery Pack
FDA UDI
DEFIBTECH, L.L.C.·00815098020379·
DDU-1XX Pediatric Rescue Pads
FDA UDI
DEFIBTECH, L.L.C.·00815098020430·
X-SMART PLUS
FDA Adverse Event
Malfunction
·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EGS·December 7, 2021
X-SMART PLUS
FDA Adverse Event
Malfunction
·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EGS·December 14, 2021
X-SMART PLUS 6:1 CONTRA-ANGLE
FDA Adverse Event
Malfunction
·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EGS·March 23, 2022