METAIZEAU NAILING SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

IES, IMAGE ENHANCEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX

FDA 510(k)

FDA Class 2 ·Orthopedic

APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1

FDA 510(k)

FDA Class 2 ·Immunology

HOWMEDICA PCA COLLARED FEMORAL STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

PASSPORT M SERIES PATIENT MONITORING (INCLUDING MODELS PASSPORT 17M AND PASSPORT 12M)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

3.5MM UNIVERSAL COMPRESSION SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

ACKRAD ERCP CONTRAST DELIVERY SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ANGIOGRAPHIC X-RAY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

VITAL SIGNS MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

LIFESTYLE MV2 (TM) TORIC (POLYMACON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR (CLEAR OR TINTED)

FDA 510(k)

FDA Class 2 ·Ophthalmic

MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACETABULAR SHELLS WITH MESH INGROWTH SURFACE

FDA 510(k)

FDA Class 2 ·Orthopedic

3ML STERI-NEB SALINE - 0.9% W/V SODIUM CHLORIDE INHALATION SOLUTION USP

FDA 510(k)

FDA Class 2 ·Anesthesiology

PRODIMED MICROINJECTION PIPETTES

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

EXETER CERAMIC FEMORAL HEADS

FDA 510(k)

FDA Class 2 ·Orthopedic