CLEARTRAC CANNULA

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CODMAN LUMBAR DRAINAGE CATHETER KIT

FDA 510(k)

FDA Class 2 ·Neurology

SERENITY PRO PSF SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VISION-SCIENCES ENT-3000 SCOPE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SMITH & NEPHEW TWINFIX ULTRA PK SUTURE ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

Monoject Enteral Syringe with ENFit Connector

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

USCI(R) HEMAQUET(TM) INTRODUCER W/OBTURATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUANTUM SPINAL SYSTEM, QUANTUM MIS

FDA 510(k)

FDA Class 2 ·Orthopedic

2008K@HOME HEMODIALYSIS MACHINE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VIRGO AMA ELISA KIT

FDA 510(k)

FDA Class 2 ·Immunology

Abiomed 14Fr Low Profile Introducer Set

FDA 510(k)

FDA Class 2 ·Cardiovascular

Force Fiber Fusion Suture

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

LeadCare Plus Blood Lead Testing System

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LARGE LUMEN Y ADAPTER W/ROTATING DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

CALIBRATORS, CONTROL MATERIALS, ELECTRODES & TUBE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

THREADED ACETABULAR COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic