System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA ONE-STEP

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·OPTI-ONE(R) MULTI-PURPOSE SOLUTION

RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DAVIS AND GECK HANDHELD INST. STERILIZATION TRAY

FDA 510(k)

FDA Class 2 ·General Hospital

LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIOFIX* BIODEGRADABLE FIXATION ROD

FDA 510(k)

FDA Class 2 ·Orthopedic

LUKENS SILK SURGICAL SUTURE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

APPOSE ULTRA DISPOS. SKIN STAPLER W/AUTO RELEASE

FDA 510(k)

FDA Class 2 ·General Hospital

DEXON S, DEXON PLUS, AND DEXON II POLYCOLIC ACID

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FLEXON TEMPORARY CARDIAC CONDUCTIVE MULTIFILAMENT

FDA 510(k)

FDA Class 2 ·Cardiovascular

LUKENS NYLON SURGICAL SUTURE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PERSONAL 120/210 BASIC ELECTROCARDIOGRAPH

FDA 510(k)

FDA Class 2 ·Cardiovascular

DEXON DISSECTING SPONGE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LUKENS SURGICAL GUT SUTURE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MONITOR, MODEL 2817

FDA 510(k)

FDA Class 2 ·Cardiovascular

SURGILENE POLYPROPYLENE SUTURE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MATRIX LR, LR 22A & LR/LASER RECORDER

FDA 510(k)

FDA Class 2 ·Radiology

DAVIS+GECK VISADUCT KIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DAVIS & GECK CHROMIC & PLAIN GUT LIGATURE CARRIER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PERSONAL TRANSFER SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital