Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC INTERSTIM CONTINENCE CONTROL SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED INFUSION SYSTEM

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·INVENIA ABUS -- AUTOMATED BREAST ULTRASOUND SYSTEM

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WCD 3000 SYSTEM

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WCD 3000 SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VASCULAR DRIVER MX2 CORONARY STENT SYSTEM& MIRCODRIVER MX2 CORONARY STENT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·KENTROX SL ICD LEADS

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval

FDA Class 3 ·TMR HOLMIUM LASER SYSTEM

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBS CALCHECK

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY FOR URINARY CONTROL

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·PUREVISION(TM)(BALAFILCON A) VISIBILITY TINTED CONTACT LENSES

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·DIASORIN ETI MAK-2 PLUS ASSAY

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYS

Stimulator, Electrical, Implanted, For Essential Tremor

FDA Pre-Market Approval

FDA Class 3 ·Vercise PC, Vercise Gevia and Vercise Genus DBS Systems

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·FLOSEAL NT HEMOSTATIC MATRIX

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·DIAGNOSTIC DUETT