C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR

FDA 510(k)

FDA Class 2 ·Immunology

ACURA Stabilization System

FDA 510(k)

FDA Class 2 ·Orthopedic

MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DEPUY GLOBAL UNITE SHOULDER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CK-MB (NAC-ACT)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GI Genius

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

iBSM

FDA 510(k)

FDA Class 2 ·Cardiovascular

AllureTM Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Aerogen®Solo Nebulizer System

FDA 510(k)

FDA Class 2 ·Anesthesiology

Mobility+ Enteral Feeding System OTC

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BIPAP FOCUS

FDA 510(k)

FDA Class 2 ·Anesthesiology

Latitud Hip Replacement System

FDA 510(k)

FDA Class 2 ·Orthopedic

Wireless/ Wired X-Ray Flat Panel Detectors

FDA 510(k)

FDA Class 2 ·Radiology

Sentry IVC Filter

FDA 510(k)

FDA Class 2 ·Cardiovascular

qER

FDA 510(k)

FDA Class 2 ·Radiology

ZIECON DISC WITH COLLAR FOR CAD/CAM MODEL ZD810-26, ZIECON BLOCK FOR MOM MODEL ZB763812-20, ZB653012-21, ZB402012-20, ZI

FDA 510(k)

FDA Class 2 ·Dental

AERONEB PROFESSIONAL NEBULIZER SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

INNOVO

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EMPHASYS Femoral Stems

FDA 510(k)

FDA Class 2 ·Orthopedic

APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES

FDA 510(k)

FDA Class 2 ·Ophthalmic