110 results
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55ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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ACON OXY ONE STEP OXYCODONE TEST STRIP AND ACON OXY ONE STEP OXYCODONE TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Flowflex® Plus COVID-19 Home Test
FDA 510(k)
FDA Class 2
·Microbiology
Distinct® Early Detection Pregnancy Test
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE
FDA 510(k)
FDA Class 2
·Ophthalmic
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
FDA 510(k)
FDA Class 2
·Ophthalmic
DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric
FDA 510(k)
FDA Class 2
·Ophthalmic
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total 1 / DAILIES Total 1 Multifocal
FDA 510(k)
FDA Class 2
·Ophthalmic
LenSx Laser System
FDA 510(k)
FDA Class 2
·Ophthalmic
LenSx Laser System (8065998162)
FDA 510(k)
FDA Class 2
·Ophthalmic
DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
FDA 510(k)
FDA Class 2
·Ophthalmic
CENTURION VISION SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
FDA 510(k)
FDA Class 2
·Ophthalmic
AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal
FDA 510(k)
FDA Class 2
·Ophthalmic
Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal
FDA 510(k)
FDA Class 2
·Ophthalmic
AIR OPTIX COLORS
FDA 510(k)
FDA Class 2
·Ophthalmic
Alcon (serafilcon A) soft contact lenses for daily wear
FDA 510(k)
FDA Class 2
·Ophthalmic