9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EndoNaut
FDA 510(k)
FDA Class 2
·Radiology
INTELLIVUE PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BELIFU
FDA Adverse Event
Injury
·HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED·Product code GZJ·February 10, 2020
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014
6000 CMS
FDA Adverse Event
Malfunction
·MOOG DEVICES GROUP·Product code FRN·May 23, 2013
PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 22, 2011
RING TRANSJUGULAR INTRAHEPATIC ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·November 15, 2019
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021