Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense Continuous Glucose Monitoring System

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Zoll R series OneStep CPR Cable, R Series Onestep Pacing Cable, R Series MFC (Multi-Function Cable), Multifunction Thera

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Defibtech Automated External Defibrillator (AED) Systems

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense® E3 Continuous Glucose Monitoring (CGM) System

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·LIFEPAKAutomated External Defibrillators (AEDs)

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Powerheart® G5 AED

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·ZOLL X Series

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·samaritan Public Access Automated External Defibrillators and Accessories

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Physio-Control LIFEPAK® 20e defibrillator/monitor

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·LIFEPAK® 15 monitor

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 ·LIFEPAK® CR2 Defibrillator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·LIFEPAK® CR2 Defibrillator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·LIFEPAK Automated External Defibrillators (AEDs)

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·X Series, Propaq MD, and R Series

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense Continuous Glucose Monitoring System