SILMAX PECTORAL IMPLANT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

506 NON-INVASIVE VITAL SIGNS MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

AFINION HBALC

FDA 510(k)

FDA Class 2 ·Hematology

NEXGEN COMPLETE KNEE SOLUTION CONVEX INSET PATELLA COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

ARTERIAL EMBOLIZATION DEVICE (KRD)

FDA 510(k)

FDA Class 2 ·Cardiovascular

SYNTHES PEDIATRIC ROD SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

GE DIASONICS GATEWAY AND GATEWAY FX

FDA 510(k)

FDA Class 2 ·Radiology

CORTISOL CLASP-BEAD EIA KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PHARMULATOR

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE, TWO PASTE BONDING SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

PRESS-FIT HEAD RESURFACING DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

DIFCO DIRECTOR INOCULATION SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

MAEDA SILVER ACUPUNCTURE NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

ZIRCONIA CERAMIC MODULAR HEAD 9TYPE II TAPER

FDA 510(k)

FDA Class 2 ·Orthopedic

SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS)

FDA 510(k)

FDA Class 2 ·Orthopedic

SCEPTOR STREPTOCOCCUS MIC PANEL #80322

FDA 510(k)

FDA Class 2 ·Microbiology

EMIT II PLUS ECSTASY ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology