BIVONA(R) ICU ENDOTRACHEAL TUBE

FDA 510(k)

FDA Class 2 ·Anesthesiology

ITST Intertrochanteric/Subtrochanteric Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

ARCOM POLYETHYLENE ACETABULAR LINERS & COMPONENTS

FDA 510(k)

FDA Class 2 ·Orthopedic

CRI CYNOSAR CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC

FDA 510(k)

FDA Class 2 ·Hematology

4-WIRE (CARSON) STONE EXTRACTOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HIGH RANGE PEROXIDE TEST STRIP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CUTTERSIL MUCOSA

FDA 510(k)

FDA Class 2 ·Dental

Pediatric Nailing Platform Tibia

FDA 510(k)

FDA Class 2 ·Orthopedic

VERSA-FX FEMORAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MODULAR RADIAL HEAD REPLACEMENT DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

VAN-TEC DOUBLE SHEATH GRASPING FORCEPS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VAN-TEC C-FLEX SUPRAPUBIC BALLOON CATHETER SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ISE COMPENSATION SERA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

KINETIC 610 ETHANOL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SERALYZER ARIS PHENYTOIN REAGENT STRIPS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Gastric Sizing Balloon Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ASCENSIA ELITE DIABETES CARE SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PINNACLE REVISION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic