Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartStart FRx Defibrillator

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·GENVISC 850

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LifeVest Wearable Defibrillator

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·STELKAST SURPASS ACETABULAR SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·ARTEFILL

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·ANIMAL VIBE SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·ANIMAS VIBE SYSTEM

Aspiration Therapy System

FDA Pre-Market Approval

FDA Class 3 ·AspireAssist

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·ISPAN PERFLUOROPROPANE C3F8 GAS

Instrument, Glucose, Noninvasive Technology

FDA Pre-Market Approval

FDA Class 3 ·GLUCOWATCH G2 BIOGRAPHER

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Bellafill Dermal Filler

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·ProDisc-C Total Disc Replacement

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·Mammomat Inspiration with Tomosynthesis Option / Mammomat Revelation with Tomosynthesis Option

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval

FDA Class 3 ·Animas Vibe System

Aspiration Therapy System

FDA Pre-Market Approval

FDA Class 3 ·AspireAssist

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·LIFEPAK CR2 Automated External Defibrillator

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·LIFEPAK Automated External Defibrillator (AED)

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LifeVest Wearable Defibrillator