Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Lifeline/ReviveR, Lifeline/ReviveR Auto, Lifeline/ReviveR VIEW, Lifeline/ReviveR VIEW AUTO, Lifeline/ReviveR ECG, and Li

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Mara Water Vapor Ablation System

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·AEGEA VAPOR SYSTEM, AEGEA VAPOR PROBE PROCEDURE KIT, AEGEA VAPOR GENERATOR AND AEGEA VAPOR GENERATOR ACCESSORY KIT

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·Aspire Cristalle Digital Breast Tomosynthesis Option

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION CYROABLATION THERAPY SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Mara Water Vapor Ablation System, Mara Water Vapor System, Mara Console

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·ASPIRE Cristalle Breast Tomosynthesis System

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Mara Water Vapor Ablation System

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Mara Water Vapor Ablation System; Mara Water Vapor System; Mara Console

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Defibtech Lifeline, Defibtech Lifeline AUTO

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

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

Fluid, Hysteroscopy

FDA Pre-Market Approval

FDA Class 3 ·HYSKON (32% DEXTRAN 70)

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·MARA Water Vapor Ablation System