Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK II PROCINE BIOPROSTHETIC HEART VALVE

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700™ Inflatable Penile Prosthesis

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·MOSAIC PORCINE BIOPROSTHETIC HEART VALVE

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PHACOFLEX II(R) SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Consulta CRT-P, Syncra CRT-P

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRTD, Cobalt M

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Aurora EV-ICD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Series Product Line/ Implantable Penile Prosthesis (IPP) with and without Inhibizone Treatment

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC EN-TRUST 30J/35J ICD FAMILY

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·COSMOS II(R) PULSE GENERATORS MODEL 283-03, 284-05

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC REVEAL PLUS INSERTABLE LOOP RECORDER (ILR) APPLICATION SOFTWARE MODEL 9809

Implant, Resorbable, For Articular Osteochondral Repair

FDA Pre-Market Approval

FDA Class 3 ·Agili-C

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBsAg Qualitative Reagent, ARCHITECT HBsAg Qualitative Confirmatory Reagent, Alinity i HBsAg Qualitative II Re

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity (comfilcon A) XR Toric and Toric Multifocal Soft (Hydrophilic) Contact Lenses for Extended Wear

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC REVEAL PLUS INSERTABLE LOOP RECORDER (ILR) WITH UPDATED TO THE APPLICATION SOFTWARE (MODEL 09-9 SERIES 2.0)

Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

FDA classification

FDA Class 3 ·Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter