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

FDA Pre-Market Approval

FDA Class 3 ·QDOT MICRO Navigation Catheter

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·EURO DR, DRT, SR, SR-T; EFFECTA D, DR, S, SR; ELUNA E DR-T PROMRI, 8 DRPROMRI; ELUNA 8 DR-T PROMRI; ELUNA 8 SR-T PROMRI;

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·IGOTIS 5 HF-T (DF-4), 7 HF-T (DF-4, LI); IFORIA 7 HF-T (DF4, GB) IIESTO 5 HF-TIESTO 5 HF-T (DF-4)

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·ELUNA 8 HF-T; ENTOVIS HF, ENTOVIS HF-T, EPYRA 8 HF-T

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

FDA Pre-Market Approval

FDA Class 3 ·BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BIOSENSE WEBSTER CABLES

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER

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

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN XT Transcatheter Heart Valve

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·SmartAblate Irrigation Tubing Set

Drug-Eluting Sinus Stent

FDA Pre-Market Approval

FDA Class 3 ·PROPEL

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Toric II 1-Piece IOLs, TECNIS Symfony Toric II Extended Range of Vision IOLs

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Multifocal Toric II Intraocular Lenses

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·Adherus AutoSpray Dural and ET Dural Sealant

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartStart FRx Defibrillator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartStart FRx Defibrillator

Over-The-Counter Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·M5071A HS1 Adult SMART Pads Cartridge, M5072A HS1 Infant/Child SMART Pads Cartridge

Over-The-Counter Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·HeartStart OnSite Defibrillator, HeartStart Home Defibrillator, HeartStart HS1 SMART Pads, Adult, HeartStart HS1 SMART P