AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA

FDA 510(k)

FDA Class 2 ·Immunology

ATHENA MULTI-LYTE GBM TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

PRECLUDE IMA SLEEVE

FDA 510(k)

FDA Class 2 ·Cardiovascular

GORE PRECLUDE VESSEL GUARD

FDA 510(k)

FDA Class 2 ·Cardiovascular

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 CHLORAMPHENICOL

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

12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models)

FDA 510(k)

FDA Class 2 ·Radiology

NH-2002

FDA 510(k)

FDA Class 2 ·Neurology

NTI-1000

FDA 510(k)

FDA Class 2 ·Neurology

Modius Sleep

FDA 510(k)

FDA Class 2 ·Neurology

BIOTRON 18

FDA 510(k)

FDA Class 2 ·Neurology

Galen™ Second Read™

FDA 510(k)

FDA Class 2 ·Pathology

ELEXOMA MEDIC

FDA 510(k)

FDA Class 2 ·Neurology

CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C

FDA 510(k)

FDA Class 2 ·Neurology

Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)

FDA 510(k)

FDA Class 2 ·Microbiology

BR-2 BIOREST

FDA 510(k)

FDA Class 2 ·Neurology