DENTACOLOR(R) CRE-ACTIVE

FDA 510(k)

FDA Class 2 ·Dental

S-TEST CREATININE (CRE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)

FDA 510(k)

FDA Class 2 ·General Hospital

Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

R&G Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

QUANTA LITE PBC SCREEN IGG/IGA ELISA

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE GP210 ELISA

FDA 510(k)

FDA Class 2 ·Immunology

APNEA RISK EVALUATION SYSTEM (ARES)

FDA 510(k)

FDA Class 2 ·Anesthesiology

CRE Pulmonary Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CRE(TM) BALLOON DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Auris Robotic Endoscopy System (ARES)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

APNEA RISK EVALUATION SYSTEM (ARES)

FDA 510(k)

FDA Class 2 ·Anesthesiology

APNEA RISK EVALUATION SYSTEM (ARES)

FDA 510(k)

FDA Class 2 ·Anesthesiology

MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER

FDA 510(k)

FDA Class 2 ·Neurology

APNEA RISK EVALUATION SYSTEM (ARES)

FDA 510(k)

FDA Class 2 ·Anesthesiology

KEY CHAIN EMERGENCY AIRWAY

FDA 510(k)

FDA Class 2 ·Anesthesiology

VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VAPORTOMME VAPORIZATION LOOP (GVE-LG)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS

FDA 510(k)

FDA Class 2 ·General Hospital

UVATAN INDUS. UVATAN 900C, 900B/800 & 600C

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery