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Cefla S.C.

FDA 510(k) & PMA Approved Devices — 15 products

Total Devices15
Categories7
Latest FDA decision2026-05-04
TypeNumberDevice NameCodeDateActions
510(k) K260716 NeowiseLLZ2026-05-04 View
510(k) K252353 myray ProXIma X6OAS2026-03-10 View
510(k) K230895 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,EBW2024-04-01 View
510(k) K231990 Apex LocatorLQY2024-02-13 View
510(k) K223794 hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSOAS2023-01-17 View
510(k) K213022 CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LEDEBW2022-05-09 View
510(k) K220664 NewTom 7GJAK2022-05-06 View
510(k) K214084 hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSOAS2022-01-20 View
510(k) K200688 hyperion X5, NewTom GO, X-RADiUS COMPACTOAS2020-04-09 View
510(k) K190496 hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSOAS2019-04-24 View
510(k) K183448 NewTom 5G XLJAK2019-03-08 View
510(k) K161848 Family of Steam sterilizers B17 B22 SeriesFLE2017-02-23 View
510(k) K163519 RX DCEHD2017-01-13 View
510(k) K161900 HYPERION X5OAS2016-12-09 View
510(k) K151597 Family of Steam Sterilizers B 28 seriesFLE2016-03-04 View
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