PULSE CRP TEST

FDA 510(k)

FDA Class 2 ·Immunology

PULSE RF TEST

FDA 510(k)

FDA Class 2 ·Immunology

TEX-AID BLUE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PULSE IM RED CELL TEST

FDA 510(k)

FDA Class 2 ·Immunology

Whisper Pump System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ELF

FDA 510(k)

FDA Class 2 ·Anesthesiology

S&W ELECTRODE TYPES 888, 844, 988 AND 944

FDA 510(k)

FDA Class 2 ·Cardiovascular

SILVERFIL

FDA 510(k)

FDA Class 2 ·Dental

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENS PLUS(R) OXYSEPT(R) ONE STEP NEUTRAL. TABLET

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI PROBE III BALLOON-ON-A-WIRE DILATATION SYSTEM

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENS PLUS(R) OXYSEPT(R) ONE STEP NEUTRAL. TABLET

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENS PLUS(R) OXYSEPT(R) ONE STEP NEUTRAL. TABLET

SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

PHILIPS HERCEPTEST DIGITAL SCORE

FDA 510(k)

FDA Class 2 ·Hematology

Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)

FDA 510(k)

FDA Class 2 ·General Hospital

RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA

FDA 510(k)

FDA Class 2 ·Hematology

CASTLE 7515 UTENSIL/GLASSWARE WASHER

FDA 510(k)

FDA Class 2 ·General Hospital

MEDNOVA BLOOD PRESSURE CUFF

FDA 510(k)

FDA Class 2 ·Cardiovascular

AUTOMATIC DIGITAL BLOOD PRESSURE METERS, MODELS

FDA 510(k)

FDA Class 2 ·Cardiovascular

TP AND DESIGN, CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology