HEALIX ADVANCE Anchor with DYNACORD Suture

FDA 510(k)

FDA Class 2 ·Orthopedic

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ORAQUICK HCV RAPID ANTIBODY TEST

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETERS

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Dimension TPSA Flex reagent cartridge

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT

Sunlamp Products (Pre-Standard)

FDA classification

FDA Class 2 ·Sunlamp Products (Pre-Standard)

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Dimension Vista TPSA Flex reagent cartridge

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Dimension Vista TPSA Flex reagent cartridge (K6451)

Dilator, Vessel, For Percutaneous Catheterization

FDA classification

FDA Class 2 ·Dilator, Vessel, For Percutaneous Catheterization

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV RNA QUALITATIVE ASSAY/APTIMA HCV RNA QUALITATIVE ASSAY

Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DEX Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SUCTION LIPOPLASTY ACCESSORIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

POLYPERF / POLYPERF SAFE

FDA 510(k)

FDA Class 2 ·General Hospital

CADI, VERSION 4

FDA 510(k)

FDA Class 2 ·Radiology

SPEEDTRAP Graft Preparation System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VX130 Ophthalmic Diagnostic Device

FDA 510(k)

FDA Class 2 ·Ophthalmic