Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·INFORM HER2 DUAL ISH DNA PROBE COCKTAIL

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Implantable System for Remodulin

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System and Ascenda Intrathecal Catheters

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

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

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·SNS Urinary: InterStim Therapy System and Verify Evaluation System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED NC BIB RANGER PTCA CATHETER

Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla

FDA Pre-Market Approval

FDA Class 2 ·NEODYMIUM-YAG OP LASER OPL-3

Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla

FDA Pre-Market Approval

FDA Class 2 ·NEODYMIUM-YAG OP LASER OPL-3

Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla

FDA Pre-Market Approval

FDA Class 2 ·NEODYMIUM-YAG OP LASER OPL-3

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NC BIG RANGER PTCA CATHETER

Susceptibility Test Powders, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VIBRAMYCIN DIAG. SUSCEPTIBILITY POWDER (DOXYCYCLIN

Kit, Assay, Estrogen Receptor

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT ER-EIA MONOCLONAL DIAG. KIT

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER

Susceptibility Test Powders, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·POTASSIUM PENICILLIN G DIAG SYS POWDER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Webster Diag./Ablation Deflectable Tip Catheter

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Webster Diag/ Ablation Deflectable Tip Catheter