Prosthesis, Testicular

FDA Pre-Market Approval

FDA Class 3 ·SALINE-FILLED TESTICULAR PROSTHESIS

Device, Testicular Hypothermia

FDA Pre-Market Approval

FDA Class 3 ·REPRO-MED - THD ADDRESS CHANGE / MANU. FACILITY

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·SNS Urinary interStim Therapy System and Verify Evaluation System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System, SNS Urinary Leads

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Obalon Touch Dispenser

Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

FDA Pre-Market Approval

FDA Class 3 ·AMS UROLUME ENDOPROSTHESIS

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

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

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY/INTERSTIM II

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval

FDA Class 3 ·Therakos Uvar XTS Photopheresis System Procedural Kit.

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·Coaptite

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·PRISMAFLEX TPE 2000 SET

Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

FDA Pre-Market Approval

FDA Class 3 ·UROLUME ENDOPROSTHESIS

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700™ Inflatable Penile Prosthesis (IPP) with and without InhibiZone™

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System and Verify Evaluation System (SNS Urinary Programming Systems)

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOTHERAPY FOR BPH

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·RESHAPE INTEGRATED DUAL BALLOON SYSTEM

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·RESHAPE INTEGRATED DUAL BALLOON SYSTEM, RESHAPE BALLOON ASSEMBLY, RESHAPE REMOVAL CATHETER, RESHAPE VALVE SEALANT

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·Titan Inflatable Penile Prosthesis