Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·DISPOSABLE FALOPE-RING BANK APPLICATOR KITS

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·MACROPLASTIQUE IMPLANTS, MPQ-2.5

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Cardiomems HF System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Genesis Neurostimulation System

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·KAMRA INLAY

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Evoke® SCS System

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Axium Neurostimulator System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·BRIO NEUROSTIMULATION SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS

System, Laser, Fiber Optic, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·OPTIGUIDE Fiber Optic Diffuser (pb 200, PB 700 Series)

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·DISPOSABLE FALOPE-RING BAND APPLICATOR KITS

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA classification

FDA Class 3 ·Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DuraSeal Exact Spine Sealant System

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DuraSeal Dural Sealant System

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·Hydrus® Microstent

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINIMED 530G SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME REVEL SYSTEM

PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS

FDA 510(k)

FDA Class 3 ·Cardiovascular

PADPRO, MODEL 2603

FDA 510(k)

FDA Class 3 ·Cardiovascular

PADPRO, MODEL 2502

FDA 510(k)

FDA Class 3 ·Cardiovascular