MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IlluminOss Photodynamic Bone Stabilization System

FDA 510(k)

FDA Class 2 ·Orthopedic

PGR HIP STEM (ENDOPROSTHESIS) FOR LARGE BONE RESEC

FDA 510(k)

FDA Class 2 ·Orthopedic

LIMA-LTO. SEM MODULAR EXTERNAL STABLIZER

FDA 510(k)

FDA Class 2 ·Orthopedic

SL-SELF LOCKING TOTAL HIP-FEMORAL COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

THERAPEUTIC DRUG STANDARD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

XPRESSE INJECTION SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

IlluminOss Photodynamic Bone Stabilization System

FDA 510(k)

FDA Class 2 ·Orthopedic

ERIS URO-DIAGNOSTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IlluminOss Photodynamic Bone Stabilization System

FDA 510(k)

FDA Class 2 ·Orthopedic

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

Tissue Adhesive For The Topical Approximation Of Skin

FDA Pre-Market Approval

FDA Class 2 ·DERMABOND(R) TOPICAL SKIN ADHESIVE

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER M1000 SYSTEM

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·HAVAB-M (R) EIA

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)

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

FDA Pre-Market Approval

FDA Class 2 ·Dimension TPSA Flex reagent cartridge (RF451)

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

FDA Pre-Market Approval

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