10,000 results · 52ms · Sources: EU EUDAMED, US FDA

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ISIGHT

FDA 510(k)
FDA Class 2 ·Ophthalmic

TOTAL BILIRUBIN REAGENT, CONCENTRATED

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

LD1 ISOENZYME REAGENT KIT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DELTON F PIT & FISSURE SEALANT

FDA 510(k)
FDA Class 2 ·Dental

TRUBYTE DENTURE BOND DENTURE BONDING AGENT

FDA 510(k)
FDA Class 2 ·Dental

SUREFLEX FILES

FDA 510(k)
FDA Class 1 ·Dental

CK-NAC 2-VIAL REAGENT W/SUBSTRATE START

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

TOTAL ETCH GEL

FDA 510(k)
FDA Class 2 ·Dental

DYRACT II RESTORATIVE

FDA 510(k)
FDA Class 2 ·Dental

ENTERSCAN

FDA 510(k)
FDA Class 2 ·Radiology

ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DYRACT(TM) MATERIAL

FDA 510(k)
FDA Class 2 ·Dental

HDL CHOLESTEROL KIT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

SPECTRUM CURING LIGHT POLYMERIZATION UNIT

FDA 510(k)
FDA Class 2 ·Dental

PRIME & BOND DIRECT COMPOSITE BONDING AGENT

FDA 510(k)
FDA Class 2 ·Dental

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·PD-L1 IHC 22C3 PharmDx

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·RESOLVE/GP(TM) DAILY CLEANER

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·RESOLVE/GP(TM) DAILY CLEANER