1,077 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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qER
FDA UDI
QURE.AI TECHNOLOGIES PRIVATE LIMITED·00860005118106·Qure.ai Head CT scan interpretation software, q...
qER-Quant
FDA UDI
QURE.AI TECHNOLOGIES PRIVATE LIMITED·00860005118137·The qER-Quant device is intended for automatic ...
qER
FDA 510(k)
FDA Class 2
·Radiology
qER-Quant
FDA 510(k)
FDA Class 2
·Radiology
qER-CTA (v1.0)
FDA 510(k)
FDA Class 2
·Radiology
TRACHEAL INTUBATION FIBERSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code EOQ·April 27, 2023
ZENITH FLEX AA ENDOVASCULAR GRAFT ILIAC LEG
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·June 14, 2011
Camera, Ophthalmic, Slit-Scanning
FDA classification
FDA Class 2
·Camera, Ophthalmic, Slit-Scanning
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological
FDA Enforcement
Class II
·Ongoing·GE Healthcare GmbH·September 25, 2024
SLM-1ER, SLM-2ER, SLM-3ER
FDA 510(k)
FDA Class 2
·Ophthalmic
FERRING PHARMACEUTICALS INC.
FDA registration
FERRING PHARMACEUTICALS INC.·1 product·🇺🇸 United States
Zirconia Opaque 1er
FDA UDI
ZIRKONZAHN SRL·D800ZRAA0101·
Nova 3
FDA UDI
QED, INC.·00860013851576·200-watt Halogen Light Source
Nova 300
FDA UDI
QED, INC.·00860013851514·300-watt Xenon Light Source
Beamer
FDA UDI
QED, INC.·00860013851507·10-watt LED Light Source
EOS
FDA UDI
QED, INC.·00860013851569·3-watt LED Portable Headlight
Altair HI 2
FDA UDI
QED, INC.·00860013851521·Fiber Optic Headlight
Centauri 2
FDA UDI
QED, INC.·00860013851552·Portable Halogen Headlight
C3
FDA UDI
QED, INC.·00860013851545·Portable LED Headlight
Altair SA
FDA UDI
QED, INC.·00860013851538·Fiber Optic Headlight