Over-The-Counter Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·HeartStart OnSite Defibrillator, HeartStart Home Defibrillator, HS1 SMART Pads, Adult, HS1 SMART Pads, Infant/Child

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA, VERSA & SENSIA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENTRUST, VISTUOSO, SECURA DR/VR & MAXIMO II DR/VR

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·OVATIO VR & DR ICDS

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PRIZM 2

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL 3

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PHILOS, CYLOS, EVIA, ENTOVIS, ESTELLA, ECURO, & EFFECTA IMPLANTABLE PACEMAKERS

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

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV/LV-T

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX ICDS AND CRT-DS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 7217D PCD(TM) TACHYARRHYTHMIA CONTROL SYS.

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 7217B PCD(TM) TACHYARRHYTHMIA CONTROL SYS.

Light Source System, Diagnostic Endoscopic

FDA Pre-Market Approval

FDA Class 3 ·KARL STORZ D-Light C PDD System

Light Source System, Diagnostic Endoscopic

FDA Pre-Market Approval

FDA Class 3 ·Karl Storz D-Light C PDD System