UNIESTER C

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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 TOBRAMYCIN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

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

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR GENTAMICIN

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

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV GENOTYPE 2.0 ASSAY (LiPA)

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR OFLOXACIN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR TETRACYCLINE

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR VANCOMYCIN

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