Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·REALIZE ADJUSTABLE GASTRIC BAND-C

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·REALIZE ADJUSTABLE GASTRIC BAND

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·ETHICON ENDO-SURGERY CURVED ADJUSTABLE GASTRIC WITH SUTURELESS PORT AND APPLIER; ETHICON ENDO-SURGERY GASTRIC BAND SUTUR

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·REALIZE ADJUSTABLE GASTRIC BAND/REALIZE INJECTION PORT

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·REALIZE ADJUSTABLE GASTRIC BANDS WITH INJECTION PORT AND APPLIER

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·REALIZE ADJUSTABLE GASTRIC BAND

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·REALIZE ADJUSTABLE GASTRIC BANDS WITH INJECTION PORT & APPLIER

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·MODEL 8005 CIRCUCOOL PUMP

Stent, Superficial Femoral Artery, Drug-Eluting

FDA Pre-Market Approval

FDA Class 3 ·ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·Bulkamid Urethral Bulking System

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 (ETAFILCON A) BRAND CONTACT LENSES

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800TM URINARY CONTROL SYSTEM WITH INHIBIZONE TREATMENT

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 TM INFLATABLE PENILE PROSTHESIS(IPP) WITH INHIBIZONE TREATMENT

P2psa

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM