ULTRACLONE 05-100 GUINEA PIG RBC

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VIDAS NEPHROCHECK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NEPHROCHECK TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ProNephro AKI™ (NGAL)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NEPHROCHECK Test System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC)

FDA 510(k)

FDA Class 2 ·Immunology

GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Acute Kidney Injury Test System

FDA classification

FDA Class 2 ·Acute Kidney Injury Test System

BIG BEN SQUARE, BIG BEN ROUND

FDA 510(k)

FDA Class 2 ·Cardiovascular

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED NC BIB RANGER PTCA CATHETER

BIG PHIL

FDA 510(k)

FDA Class 2 ·General Hospital

ZETAPHASE-DIG

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BIG BEN

FDA 510(k)

FDA Class 2 ·Cardiovascular

ULTRA-DIG

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Regenalase Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

POWERPLAY MUSCLE MASSAGER

FDA 510(k)

FDA Class 2 ·Physical Medicine

Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OREIA-Q-DIG

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VIDAS DIGOXIN (DIG)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology