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

Freedom Total Knee System (All-poly Tibial Plate)

FDA 510(k)

FDA Class 2 ·Orthopedic

Vis-U-All Low Temperature Sterilization Pouch/Tubing

FDA 510(k)

FDA Class 2 ·General Hospital

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEOCOR SABLE(TM) PTCA CATHETER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY