System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD)

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Zoll X Series Device

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE)

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 ·ZOLL R Series Device

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Infant/Child Reduced Energy Defibrillation Electrodes

Ring, Endocapsular

FDA Pre-Market Approval

FDA Class 3 ·Capsular Tension Ring (CTR)

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·GEN-PROBE ABPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Avive Automated External Defibrillator (AED) System

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·R Series MCU 20.01 software release

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST

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 ·HeartStart FRx Defibrillator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™

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 ·AED Pro Device

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® 15 Defibrillator Lithium- ion Rechargeable Battery Accessory

Ring, Endocapsular

FDA Pre-Market Approval

FDA Class 3 ·RingJect