System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·HERCEPTEST

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·HERCEPTEST

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

FDA Pre-Market Approval

FDA Class 3 ·HER2 IQFISH PHARMDX

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·HERCEPTEST KIT

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·HERCAP TEST

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

FDA Pre-Market Approval

FDA Class 3 ·HER2 FISH PHARMDX KIT

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·HERCEP TEST

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·DAKO HERCEPTEST

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·HERCEPTEST

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·DAKO HERCEPTEST

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC CARDIAC ABLATION SYSTEM

Prosthesis, Ligament, Ptfe

FDA Pre-Market Approval

FDA Class 3 ·GORE-TEX{TM} CRUCIATE LIGAMENT PROSTHESIS

Prosthesis, Ligament, Ptfe

FDA Pre-Market Approval

FDA Class 3 ·GORE-TEX{TM} CRUCIATE LIGAMENT PROSTHESIS

Prosthesis, Ligament, Ptfe

FDA Pre-Market Approval

FDA Class 3 ·GORE-TEX{TM} CRUCIATE LIGAMENT PROSTHESIS

Prosthesis, Ligament, Ptfe

FDA Pre-Market Approval

FDA Class 3 ·GORE-TEX EXPANDED PTFE PROSTHETIC LIGAMENT

Prosthesis, Ligament, Ptfe

FDA Pre-Market Approval

FDA Class 3 ·GORE-TEX{TM} CRUCIATE LIGAMENT PROSTHESIS

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·BTE FIREFLY (ADULT)

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·BTE FIREFLY (PEDIATRIC)

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·CardioMessenger Smart 4G LTE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·DataBridge 4G/LTE Adapter