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

Antigen, Id, Candida Albicans

FDA classification

FDA Class 2 ·Antigen, Id, Candida Albicans

HEMODIALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IONOMETER E-HK AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Hematology

BODY FLUID BARRIER KIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Laser, Ophthalmic

FDA Pre-Market Approval

FDA Class 2 ·HYPERION LTK SYSTEM

Laser, Ophthalmic

FDA Pre-Market Approval

FDA Class 2 ·HYPERION LTK SYSTEM

FORTEC MI-100, MI-50 DIGITAL BLOOD PRESSURE METER

FDA 510(k)

FDA Class 2 ·Cardiovascular

FORTEC MI-306, MI-327 DIGITAL THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFIED SALTEX REAGENT STRIPS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Laser, Ophthalmic

FDA Pre-Market Approval

FDA Class 2 ·SUNRISE TECHNOLOGIES HYPERION(TM) HOLMIUM LASER SYSTEM FOR LASER THERMAL KERATOPLASTY (LTK)

NEO DENTA ZIRCONIA

FDA 510(k)

FDA Class 2 ·Dental

Belun Ring

FDA 510(k)

FDA Class 2 ·Cardiovascular

Belun Ring

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology