Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·BSC CRV ENDOTAK LEADS

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·BAK/CERVICAL (BAK/C) (R) INTERBODY FUSION SYSTEM

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·BSC Wolverine Coronary Cutting Balloon

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Tunneling Tool

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

FDA Pre-Market Approval

FDA Class 3 ·BSC Intella Nav MIFI OI Ablation Cathetrs

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·BSC APEX MONORAIL & OTW PTCA DILATATION CATHETERS

Pulmonary Stent

FDA Pre-Market Approval

FDA Class 3 ·PALMAZ MULLINS XD Pulmonary Stent

Pulmonary Stent

FDA Pre-Market Approval

FDA Class 3 ·PALMAZ MULLINS XD Pulmonary Stent

Pulmonary Stent

FDA Pre-Market Approval

FDA Class 3 ·PALMAZ MULLINS XD Pulmonary Stent

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval

FDA Class 3 ·BSC WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 7220 B/C/D/E JEWEL(R) PLUS, 7202 D/E, 7219 BDE, 7221 B/C/CXDE

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM (PAFLUFOCON A,B,C )VIOLET TINT

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM 92,60,30(PAFLUFOCON A,B,C )RGP LENSES

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM (PAFLUFOCON A,B,C )CLEAR & TINTS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM 92,60,30(PAFLUFOCON A,B,C )RGP LENSES

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM (PAFLUFOCON A,B,C )CLEAR & TINTS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM 92,60,30(PAFLUFOCON A,B,C )RGP LENSES

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM 92,60,30(PAFLUFOCON A,B,C )RGP LENSES

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM 92,60,30(PAFLUFOCON A,B,C )RGP LENSES

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA Pre-Market Approval

FDA Class 3 ·FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARAWAVE™ NAV Pulsed Field Ablation C