Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·BRACAnalysis CDx

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·BRACANALYSIS CDX

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·BRACAnalysis CDx device

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS TORIC CALCULATOR

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

Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis

FDA classification

FDA Class 3 ·Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis

Microspheres Radionuclide

FDA classification

FDA Class 3 ·Microspheres Radionuclide

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

FDA classification

FDA Class 3 ·Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

Ventricular (Assist) Bypass

FDA classification

FDA Class 3 ·Ventricular (Assist) Bypass

Transcatheter Septal Occluder

FDA classification

FDA Class 3 ·Transcatheter Septal Occluder

Dc-Defibrillator, High Energy, (Including Paddles)

FDA classification

FDA Class 3 ·Dc-Defibrillator, High Energy, (Including Paddles)

Mandibular Condyle Prosthesis

FDA classification

FDA Class 3 ·Mandibular Condyle Prosthesis