Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·THE NORMALINE KIT

MHI-TM2000 LINEAR ACCELERATOR SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS

FDA 510(k)

FDA Class 2 ·Radiology

Marco Ultra M3, Marco Ultra M4

FDA 510(k)

FDA Class 2 ·Ophthalmic

MHI-TM2000 Linear Accelerator System, VERO, Imavis

FDA 510(k)

FDA Class 2 ·Radiology

Z5 Slit lamp microscope, Z2 Slit lamp microscope

FDA 510(k)

FDA Class 2 ·Ophthalmic

QUICKSCREEN ONE STEP COCAINE SCREENING TEST (9070)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CRACK-IT CHAP SCREEN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FP(HEXAFOCON A)RGP CONTACT LENS SPHERICAL/ASP(HEXAFOCON A)RGP CONTACT LENS ASPHERICAL

FDA 510(k)

FDA Class 2 ·Ophthalmic

SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ELECTROSURGICAL PENCIL WITH ELECTRODE, WP200

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIGITAL PRINTER P6000D SERIES, MODEL P6000DU

FDA 510(k)

FDA Class 2 ·Radiology

ECHOVACS

FDA 510(k)

FDA Class 2 ·Radiology

Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5

FDA 510(k)

FDA Class 2 ·Radiology

Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode)

FDA 510(k)

FDA Class 2 ·Neurology

PAP BRUSH

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DISPOSABLE SURGICAL GOWNS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIASTAT ANTI-SM/RNP

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-LA (SS-B)

FDA 510(k)

FDA Class 2 ·Immunology

DIASTAT ANTI-RO (SS-A)

FDA 510(k)

FDA Class 2 ·Immunology