UNIPRO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

UNIMIDE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MACROPORE CARDIO-WRAP (TS)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR AZTRENAM

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR AMIKACIN

ORi

FDA 510(k)

FDA Class 2 ·Anesthesiology

23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

FDA 510(k)

FDA Class 2 ·Medical Genetics

Portable Neuromodulation Stimulator (PoNS)

FDA 510(k)

FDA Class 2 ·Neurology

23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

FDA 510(k)

FDA Class 2 ·Medical Genetics

23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

FDA 510(k)

FDA Class 2 ·Medical Genetics

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR TOBRAMYCIN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEX 2 GRAM NEGATIVE AST FOR AMPICILLIN/SULBACTAM

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·OPTI-ZYME ENZYMATIC CLEANER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALCON WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID 84392

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR GENTAMICIN

BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

PHASE II GBM IGG ANTIBODY EIA TEST

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE GBM ELISA

FDA 510(k)

FDA Class 2 ·Immunology

Quell-FM

FDA 510(k)

FDA Class 2 ·Neurology

BIOPLEX VASCULITIS KIT

FDA 510(k)

FDA Class 2 ·Immunology