LACERATION TRAY

FDA 510(k)

FDA Class 2 ·General Hospital

Device, Fluidized Therapy, Dry Heat

FDA classification

FDA Class 2 ·Device, Fluidized Therapy, Dry Heat

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

Intranasal Electrostimulation Device For Dry Eye Symptoms

FDA classification

FDA Class 2 ·Intranasal Electrostimulation Device For Dry Eye Symptoms

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

Two Or More Sterilant Sterilizer

FDA classification

FDA Class 2 ·Two Or More Sterilant Sterilizer

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

Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

FDA classification

FDA Class 2 ·Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

Muscular Dystrophy Newborn Screening Test

FDA classification

FDA Class 2 ·Muscular Dystrophy Newborn Screening Test

Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System

FDA classification

FDA Class 2 ·Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ORACLE(TM) CORONARY BALLOON DILATATION CATHETER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFTLENS CLEANING & DISINFECTING SOLN.

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENS FRESH(TM) LUBRICATING & REWETTING SOLN

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR HEPATITIS C VIRUS (HCV) TEST