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) Brand Contact Lenses

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A) CONTACT LENS

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

Digital Breast Tomosynthesis

FDA classification

FDA Class 3 ·Digital Breast Tomosynthesis

Alfapump System

FDA classification

FDA Class 3 ·Alfapump System

Permanent Defibrillator Electrodes

FDA classification

FDA Class 3 ·Permanent Defibrillator Electrodes

Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

FDA classification

FDA Class 3 ·Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

Hepatitis Viral B Dna Detection

FDA classification

FDA Class 3 ·Hepatitis Viral B Dna Detection

Automated External Defibrillators (Non-Wearable)

FDA classification

FDA Class 3 ·Automated External Defibrillators (Non-Wearable)

Over-The-Counter Automated External Defibrillator

FDA classification

FDA Class 3 ·Over-The-Counter Automated External Defibrillator

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