Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Obalon Balloon Kit

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Proclaim SCS Neurostimulation System

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·ORBERA INTRAGASTRIC BALLOON

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·ORBERA Intragastric Balloon

Lithotripter, Shockwave (For Treating Gallbladder Stones)

FDA Pre-Market Approval

FDA Class 3 ·MEDSTONE STS LITHOTRIPTER

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 ·LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE

Lithotripter, Shockwave (For Treating Gallbladder Stones)

FDA Pre-Market Approval

FDA Class 3 ·MEDSTONE STS-TC/U LITHOTRIPTER

Lithotripter, Shockwave (For Treating Gallbladder Stones)

FDA Pre-Market Approval

FDA Class 3 ·MEDSTONE STS LITHOTRIPTER

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·ORBERA Intragastric Balloon System

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Obalon Balloon System

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

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