9 results
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51ms
·
Sources: EU EUDAMED, US FDA
FT INDUSTRIES, INC
FDA registration
FT INDUSTRIES, INC·1 product·🇺🇸 United States
THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code OAD·October 27, 2017
PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code MTD·February 21, 2018
Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR and BE 183 SUR-12 Manual Jet Ventilators with Regulator and Gauge; BE 183-2 4 ft. Small Bore Tubing Assembly w/Inline Filter; and BE 183-R Regulator The BE 183-SUR and BE 183-SU Manual Jet Ventilators are designed to provide transtracheal ventilation in specific emergency situations of upper airway obstructions.
FDA Recall
Terminated
·Instrumentation Industries Inc·Product code BTL·September 7, 2012
mdi Europa GmbH
Authorized representative
🇩🇪 Germany·132 Manufacturers·4741 Devices
Sharkmed Oy
Importer
🇫🇮 Finland·18 Manufacturers
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
MedNet EC-REP GmbH
Authorized representative
🇩🇪 Germany·464 Manufacturers·5263 Devices
RIOMAVIX LTD
Authorized representative
🇪🇸 Spain·400 Manufacturers·4531 Devices