Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·HALL (TM) EASY-FIT PROSTHETIC HEART VALVE

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

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·TMJ Concepts Patient-Fitted Temporomandibular Joint (TMJ) st

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC HALL PROSTHETIC HEART VALVE /HALL EASY FIT

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories

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

FDA Pre-Market Approval

FDA Class 3 ·POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories

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

FDA Pre-Market Approval

FDA Class 3 ·POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·OCUSIL(R) (NEFOCON A) CONTACT LENSES ADD FIN LABS

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

FDA Pre-Market Approval

FDA Class 3 ·POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·PASSIVE PLUS DX STEROID ELUTING, ENDOCARDIAL PACING LEADS

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC HALL PROSTHETIC HEART VALVE/EASY-FIT/AORTIC VALVED CONDUIT/COLLAGEN IMPREGNATED CONDUIT/ROTATABLE AORTIC

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·NEXGEN COMPLETE KNEE SOLUTION

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·DRG Small/Big Curve Delivery Sheath Kit, 22cm; DRG Lead Accessories Kit; SlimTip DRG Trial Lead Kit, 50cm and 90cm; Slim

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

FDA classification

FDA Class 3 ·Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA classification

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

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

FDA classification

FDA Class 3 ·Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer