SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515

FDA 510(k)

FDA Class 2 ·Cardiovascular

OSS LES PROXIMAL FEMORAL COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

MASTERSL FEMORAL STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SCOTCHBOND 2 ADHESIVE W/SCOTCHPREP DENTIN PRIMER

FDA 510(k)

FDA Class 2 ·Dental

NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACCU-CHECK COMBO SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

KMC KYPHOPLASTY SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Biodesign Fistula Plug

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIOMET SCK KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO INTRASTENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SYNETEC

FDA 510(k)

FDA Class 2 ·Cardiovascular

DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

SCIMED VIPER CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SKINTACT AND VARIOUS OTHER TRADENAMES

FDA 510(k)

FDA Class 2 ·Cardiovascular

MONARC SLING SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NeurAxis IB-Stim (01-1020)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Threshold Pedicular Fixation System, Palisade Pedicular Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Level 1 Convective Warmer

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIAGNOSTIC ULTRASOUND TRANDUCER

FDA 510(k)

FDA Class 2 ·Radiology