QUANTASE PHENYLALANINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIASTAT TOTAL ANTI-CARDIOLIPIN KIT

FDA 510(k)

FDA Class 2 ·Immunology

SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

CARIESCAN PRO

FDA 510(k)

FDA Class 2 ·Dental

SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200

FDA 510(k)

FDA Class 2 ·Hematology

FREEMAN UNI-COMPARTMENTAL KNEE

FDA 510(k)

FDA Class 2 ·Orthopedic

MUELLER CURVED STEM HEMI-PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

DAY STAPLE

FDA 510(k)

FDA Class 2 ·Orthopedic

MULLER SELF LOCKING TOTAL HIP

FDA 510(k)

FDA Class 2 ·Orthopedic

FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP

FDA 510(k)

FDA Class 2 ·Orthopedic

360CAS

FDA 510(k)

FDA Class 2 ·Neurology

PERITRON PERINEOMETER MODEL 9300V OR 9300A

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MEDICAL TREATMENT CHAIR, T400, T500,T600

FDA 510(k)

FDA Class 2 ·Physical Medicine

SPHYGMOCOR XCEL

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

PERSONAL INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

PER, MODEL MEMO

FDA 510(k)

FDA Class 2 ·Cardiovascular

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENSOAK

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENSRINS(R) STERILE PRESERVED SALINE SOLN

Sterilizer, Soft-Lens, Thermal, Ac-Powered

FDA Pre-Market Approval

FDA Class 2 ·MODEL NO. ALS-IV HEAT DISINFECTION UNIT