Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON SENOFILCON A BRAND CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A) CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (senofilcon A) Brand Contact Lenses

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SULZER CARBOMEDICS CARBO-SEAL ASCENDING AORTIC PROSTHESIS

PM CEMENTLESS SCREW-IN ACETABULAR CUP

FDA 510(k)

FDA Class 3 ·Orthopedic

VS-1 MODEL NUMBER 251K PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A)

FDA 510(k)

FDA Class 3 ·Cardiovascular

PROGRAMALITH III 240 PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

PROGRAMALITH III MODEL 249 PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE

FDA 510(k)

FDA Class 3 ·Cardiovascular

700-FR SERIES RADIOLUCENT STIMULATION ELECTRODES

FDA 510(k)

FDA Class 3 ·Cardiovascular

CHIROFLEX II LENS MICROSERT(TM)

FDA 510(k)

FDA Class 3 ·Ophthalmic

MODEL 1148T TRANSVENOUS, SCREW-IN LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

700-SP SERIES DISPOSABLE STIMULATION ELECTRODES

FDA 510(k)

FDA Class 3 ·Cardiovascular

ENDOCARDIAL SCREW-IN LEAD MODEL 1020T

FDA 510(k)

FDA Class 3 ·Cardiovascular

LEADS UTILIZ VOLUN STAND #1 3.2 MM UNI/BIOPOLAR CO

FDA 510(k)

FDA Class 3 ·Cardiovascular

AECD ARRHYTHMIA DETECTION SOFTWARE

FDA 510(k)

FDA Class 3 ·Cardiovascular

ASCEND

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

SAMARITAN AED, MODEL SAM-01

FDA 510(k)

FDA Class 3 ·Cardiovascular

BIO-PEN CALCULATOR

FDA 510(k)

FDA Class 3 ·Unknown