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Cefla S.C. FDA Approvals

0 new drug approvals and 8 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
Neowise510(k)May 4, 2026Radiology
myray ProXIma X6510(k)Mar 10, 2026Radiology
CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4,510(k)Apr 1, 2024Dental
Apex Locator510(k)Feb 13, 2024
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS510(k)Jan 17, 2023Radiology
CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED510(k)May 9, 2022Dental
NewTom 7G510(k)May 6, 2022Radiology
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS510(k)Jan 20, 2022Radiology

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