Sensor, Glucose, Invasive, Non-Adjunctive

FDA Pre-Market Approval

FDA Class 3 ·Simplera (TM) System

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·EMDOGAIN

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·Invenia ABUS Premium, Invenia ABUS Prime

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·Invenia ABUS 2.0 Automated Breast Ultrasound System

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·INVENIA ABUS-AUTOMATED BREAST ULTRASOUND SYSTEM

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·Straumann® Emdogain®

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·BIORA EMDOGAIN(R)

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·GEMS 21S (GROWTH-FACTOR ENHANCED MATRIX)

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·EMDOGAIN

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·GEM 21S GROWTH FACTOR ENHANCED MATRIX

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·Straumann Emdogain

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 4000 LIFEVEST

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NeuroPace RNS System

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·Cervical-Stim

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·Spinal-Stim

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NeuroPace RNS System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFLENS (POLYMACON) CONTACT LENSES

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

Implanted Fecal Incontinence Device

FDA classification

FDA Class 3 ·Implanted Fecal Incontinence Device