Muscular Dystrophy Newborn Screening Test

FDA classification

FDA Class 2 ·Muscular Dystrophy Newborn Screening Test

LMT-3000

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

I-CHROMA IFOB WITH I-CHROMA READER

FDA 510(k)

FDA Class 2 ·Hematology

Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

FDA classification

FDA Class 2 ·Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Multiple Use Blood Lancet For Single Patient Use Only

FDA classification

FDA Class 2 ·Multiple Use Blood Lancet For Single Patient Use Only

Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System

FDA classification

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

MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage

FDA 510(k)

FDA Class 2 ·Orthopedic

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

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·FONAR NMR WHOLE BODY SCANNER BETA 3000

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·RIGID GAS PERMEABLE CONTACT LENSES

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR AMIKACIN

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALLERGAN PRESERVED SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALLERGAN(R) PRESERVED SALINE SOL.SPEC CHANGE

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·ROCHE AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LC-65 DAILY CONTACT LENS CLEANER