REVISED LABELING FOR METHAQUALONE TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

REVISED LABELING FOR BARBITURATE TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MODIFIED IMIPENEM SUSCEPTIBILITY POWDER

FDA 510(k)

FDA Class 2 ·Microbiology

ABUSCREEN(R) EIA AMPHETAMINE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

UP-DF500 FILMSTATION DIGITAL FILM IMAGER

FDA 510(k)

FDA Class 2 ·Radiology

SHARPLAN LASERS, INC SILKTOUCH 2 FLASH SCANNER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTS

FDA 510(k)

FDA Class 2 ·Orthopedic

WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD

FDA 510(k)

FDA Class 2 ·Orthopedic

ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DOUGLAS MEDICAL PRODUCTS, INC. VENTED SPIKE ADAPT

FDA 510(k)

FDA Class 2 ·General Hospital

ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT

FDA 510(k)

FDA Class 2 ·General Hospital

Advance Medical Designs, Inc. Sterile Ultrasound Gel

FDA 510(k)

FDA Class 2 ·Radiology

SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SUNTANNING BED, INC. T12 UVA TANNING LAMPS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MEDLINE INDUSTRIES, INC. ORTHOPEDIC TRAYS/KITS/PACKS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BLACKSTONE MEDICAL, INC. LAPAROSCOPIC DISC REMOVAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Remington Medical, Inc. Automatic Cutting Needle (NAC)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery