Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV

VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag

FDA 510(k)

FDA Class 2 ·General Hospital

VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag

FDA 510(k)

FDA Class 2 ·General Hospital

VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING

FDA 510(k)

FDA Class 2 ·General Hospital

AXIOM TOTAL KNEE SYSTEM, ALL POLY TIBIAL TRAY

FDA 510(k)

FDA Class 2 ·Orthopedic

Vis-U-All Low Temperature Sterilization Pouch/Tubing

FDA 510(k)

FDA Class 2 ·General Hospital

ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS

FDA 510(k)

FDA Class 2 ·Orthopedic

MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Vis-U-All Low Temperature Sterilization Pouch/Tubing

FDA 510(k)

FDA Class 2 ·General Hospital

Vis-U-All Low Temperature Sterilization Pouch/Tubing

FDA 510(k)

FDA Class 2 ·General Hospital

TruShot with Y-Knot Shallow All-Suture Anchor

FDA 510(k)

FDA Class 2 ·Orthopedic

DEPUY AMK ALL POLYETHYLENE POSTERIOR STABLILIZED TIBIAL TRAY

FDA 510(k)

FDA Class 2 ·Orthopedic

OGDEN ANCHOR FOR ALL ORTHOPAEDIC SOFT TISSUE APPLICATIONS

FDA 510(k)

FDA Class 2 ·Orthopedic

SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS

FDA 510(k)

FDA Class 2 ·Orthopedic

Viramed Borrela All-In-One ViraChip Test Kit

FDA 510(k)

FDA Class 2 ·Microbiology

FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Paradigm All-Suture Anchor 1.8mm, White/Black #2

FDA 510(k)

FDA Class 2 ·Orthopedic

NeuroStar Advanced Therapy System (All previously cleared models)

FDA 510(k)

FDA Class 2 ·Neurology

SAUFLON ALL-IN-ONE LIGHT CONTACT LENS SOLUTION

FDA 510(k)

FDA Class 2 ·Ophthalmic