SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003

FDA 510(k)

FDA Class 2 ·General Hospital

YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Discography Kit

FDA classification

FDA Class 2 ·Discography Kit

Droplet Digital Pcr System

FDA classification

FDA Class 2 ·Droplet Digital Pcr System

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·BREAST COMPANION SOFTWARE SYSTEM

Essence 55SP Large Monitor System

FDA 510(k)

FDA Class 2 ·Cardiovascular

6MP Color LCD Monitor (C61W+)

FDA 510(k)

FDA Class 2 ·Radiology

2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+

FDA 510(k)

FDA Class 2 ·Radiology

RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+

FDA 510(k)

FDA Class 2 ·Radiology

8MP Color LCD Monitor (C81W+)

FDA 510(k)

FDA Class 2 ·Radiology

3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+

FDA 510(k)

FDA Class 2 ·Radiology

5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+

FDA 510(k)

FDA Class 2 ·Radiology

2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)

FDA 510(k)

FDA Class 2 ·Radiology

Essence 55S Large Monitor System

FDA 510(k)

FDA Class 2 ·Cardiovascular

U.S. IOL PHACO HANDPIECE

FDA 510(k)

FDA Class 2 ·Ophthalmic

PHACO TIP

FDA 510(k)

FDA Class 2 ·Ophthalmic

EVOLUTION PHACOMULSIFIER

FDA 510(k)

FDA Class 2 ·Ophthalmic

T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry