Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 530G System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Implantable Cardioverter Defibrillator (Non-CRT)

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·AFP RIA KIT

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval

FDA Class 3 ·MiSight 1 Day (omafilcon A)

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·LIFE PULSE HIGH FREQUENCY JET VENTILATOR

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC III

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM SEVEN SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PRODIGY IPG 8158

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·KAINOX VCS,LINOX,LINOX SMART,VIGILA,VOLTA

Catheter, Balloon, Transcervical

FDA Pre-Market Approval

FDA Class 3 ·THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia/Advisa DR/Advisa DR MRI/Advisa SR MRI/ASTRA S DR MRI/ASTRA S SR MRI/ASTRA XT DR MRI/ASTRA XT SR MR

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·METHAFILCON A AND METHAFILCON B SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA, SOLETRA, KINETRA

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ENDEAVOR & ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 600/700/650/800/900 IPG & ENPULSE/ENRHYTHM/ADAPTA/VERSA/SENSIA IPG

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX MRI LEAD

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA CRT-P, SYNCRA CRT-P. VIVA CRT-P

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI IPG

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL ORIGINAL/SURGICEL FIBRILLAR/SURGICEL NU-KNIT ABSORBABLE HEMOSTATS