SMAXEL CO2 Surgical Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Q-Switched Nd:YAG Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INFUSIONCATH

FDA 510(k)

FDA Class 2 ·Cardiovascular

SHINY RPL System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PICOSECOND Nd:YAG Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION

FDA 510(k)

FDA Class 2 ·Microbiology

VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE

FDA 510(k)

FDA Class 2 ·Microbiology

VELOGENE RAPID MRSA IDENTIFICATION ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

CANDIDA DETECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

CANDIDA IMMUNODIFFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS

FDA 510(k)

FDA Class 2 ·Microbiology

DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST

FDA 510(k)

FDA Class 2 ·Microbiology

Reflect Implant System

FDA 510(k)

FDA Class 2 ·Dental

iDart Lyme IgM ImmunoBlot Kit

FDA 510(k)

FDA Class 2 ·Microbiology

ID LIGHT CURE SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit

FDA 510(k)

FDA Class 2 ·Microbiology

iDart Lyme IgG ImmunoBlot Kit

FDA 510(k)

FDA Class 2 ·Microbiology

ID MILLENNIUM, ID MOMENTS SILICONE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALCON MULTI-PURPOSE SOLUTION ID 81573