Light Source System, Diagnostic Endoscopic

FDA Pre-Market Approval

FDA Class 3 ·KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·DEFLUX INJECTABLE GEL

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 ARTIFICIAL URINARY SPHINCTER

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System (Urinary)

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·SOLESTA INJECTABLE GEL

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System and Verify Evaluation System (SNS Bowel)

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·Gambro Prismaflex TPE 2000 Set

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

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

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval

FDA Class 3 ·OrganOx metra System

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·ReShape Integrated Dual Ballon System

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·ORBERA Intragastric Balloon (IGB) System, Endoline Punc

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 INFLATABLE PENILE PROSTHESIS

Neuromodulator For Obesity

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO RECHARGEABLE SYSTEM

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·Deflux Injectable Gel

1070/15 TO 1078/17 VARIOUS TYPES NEEDLE HOLDERS

FDA 510(k)

FDA Class 3 ·Unknown

THERAPEUTIC EXCHANGE SYSTEM

FDA 510(k)

FDA Class 3 ·Unknown

AMS SPHINCTER 800 URINARY PROSTHESIS

FDA 510(k)

FDA Class 3 ·Unknown

THE ARTIFICIAL URINARY SPHINCTER

FDA 510(k)

FDA Class 3 ·Unknown

MOTIONSPECT

FDA 510(k)

FDA Class 3 ·Unknown