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

FDA Pre-Market Approval

FDA Class 3 ·QuickFlex u and Quartet leads

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THE COOL POINT IRRIGATION PUMP

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards INSPIRIS RESILIA Aortic Valve and Edwards Pericardial Aortic Bioprosthesis

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

FDA Pre-Market Approval

FDA Class 3 ·PROMOTE, QUADRA ASSURA, UNITY, UNITY ASSURA, UNIFY QUADRA FAMILIES CRT-D DEVICES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY/INTERGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·COBAS HPV TEST

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

FDA Pre-Market Approval

FDA Class 3 ·Aveir™ Leadless System (Dual-Chamber)

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·cobas HPV TEST

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NEUROPACE RNS SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·TRANSCATHER HEART VALVE AND TRANSFEMORAL ACCESSORIES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ANTERIOR CHAMBER MONOFOCAL

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINIMED 630G SYSTEM WITH SMARTGUARD

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval

FDA Class 3 ·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STYLES 31-34 POSTERIOR IOLS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PORCINE BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESES WITH THERMAFIX TISSUE PROCESS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE FAMILY OF ICDS

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval

FDA Class 3 ·T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM