Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·AEGEA VAPOR SYSTEM, AEGEA VAPOR PROBE PROCEDURE KIT, AEGEA VAPOR GENERATOR AND AEGEA VAPOR GENERATOR ACCESSORY KIT

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NeuroPace RNS System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED & ISOMED DRUG INFUSION SYSTEMS

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa™ and Percept™ Deep Brain Stimulation Therapy System

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·GELFOAM (ABSORBABLE GELATIN) STERILE SPONGE

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·HER2 FISH PHARMDX KIT

Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion

FDA Pre-Market Approval

FDA Class 3 ·DAKO TOP2A FISH PHARMDX KIT

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Saluda Medical Evoke® SCS System

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Avitene Flowable Collagen Hemostat

Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

FDA Pre-Market Approval

FDA Class 3 ·UROVYSION BLADDER CANCER KIT,PROBECHEK CONTROL SLIDES FOR UROVYSION BLADDER CANCER KIT

Device, Removal, Pacemaker Electrode, Percutaneous

FDA Pre-Market Approval

FDA Class 3 ·SPECTRANETICS LASER SHEATH

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·SCS ACCESSORY KIT

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

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 ·INTERSTIM THERAPY: TORQUE WRENCH AND BOOK KIT, MODEL 3550-80

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·Artic Front Cryocatheter System

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·FALOPE-RING(R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·Vysis ALK Break Apart Fish Probe Kit

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ETI-AB-AUK PLUS Assay