DURAFLOR

FDA 510(k)

FDA Class 2 ·Dental

Light Based Device For Dry Age-Related Macular Degeneration

FDA classification

FDA Class 2 ·Light Based Device For Dry Age-Related Macular Degeneration

ß-Glucocerebrosidase (Gba) Newborn Screening Test System

FDA classification

FDA Class 2 ·ß-Glucocerebrosidase (Gba) Newborn Screening Test System

Alpha-D-Glucosidase (Gaa) Newborn Screening Test System

FDA classification

FDA Class 2 ·Alpha-D-Glucosidase (Gaa) Newborn Screening Test System

Alpha-L-Iduronidase (Idua) Newborn Screening Test System

FDA classification

FDA Class 2 ·Alpha-L-Iduronidase (Idua) Newborn Screening Test System

Alpha-D-Galactosidase A (Gla) Newborn Screening Test System

FDA classification

FDA Class 2 ·Alpha-D-Galactosidase A (Gla) Newborn Screening Test System

Intranasal Electrostimulation Device For Dry Eye Symptoms

FDA classification

FDA Class 2 ·Intranasal Electrostimulation Device For Dry Eye Symptoms

Oral Electronic Vision Aid

FDA classification

FDA Class 2 ·Oral Electronic Vision Aid

Two Or More Sterilant Sterilizer

FDA classification

FDA Class 2 ·Two Or More Sterilant Sterilizer

Sterilizer, Dry Heat

FDA classification

FDA Class 2 ·Sterilizer, Dry Heat

Calculator, Drug Dose

FDA classification

FDA Class 2 ·Calculator, Drug Dose

Calibrators, Drug Specific

FDA classification

FDA Class 2 ·Calibrators, Drug Specific

Calibrators, Drug Mixture

FDA classification

FDA Class 2 ·Calibrators, Drug Mixture

ß-Galactocerebrosidase (Galc) Newborn Screening Test System

FDA classification

FDA Class 2 ·ß-Galactocerebrosidase (Galc) Newborn Screening Test System

Acid-Sphingomyelinase (Asm) Newborn Screening Test System

FDA classification

FDA Class 2 ·Acid-Sphingomyelinase (Asm) Newborn Screening Test System

Radioceptor Assay, Neuroleptic Drugs

FDA classification

FDA Class 2 ·Radioceptor Assay, Neuroleptic Drugs

Radioimmunoassay, Tricyclic Antidepressant Drugs

FDA classification

FDA Class 2 ·Radioimmunoassay, Tricyclic Antidepressant Drugs

Immunoassay, Anti-Seizure Drug

FDA classification

FDA Class 2 ·Immunoassay, Anti-Seizure Drug

Muscular Dystrophy Newborn Screening Test

FDA classification

FDA Class 2 ·Muscular Dystrophy Newborn Screening Test

Device, Fluidized Therapy, Dry Heat

FDA classification

FDA Class 2 ·Device, Fluidized Therapy, Dry Heat