Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·cobas EGFR Mutation Test v2

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·cobas EGFR Mutation Test v2

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Cobas EGFR Mutation Test v2, Cobas DNA and cfDNA Sample Preparation Kit

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Obalon Balloon System with Navigation and Touch

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·OBALON BALLOON SYSTEM

Apparatus, Electronanesthesia

FDA classification

FDA Class 3 ·Apparatus, Electronanesthesia

Lens, Intraocular, Toric Optics

FDA classification

FDA Class 3 ·Lens, Intraocular, Toric Optics

Ophthalmic Sealant

FDA classification

FDA Class 3 ·Ophthalmic Sealant

Prosthesis, Hip, Constrained, Metal

FDA classification

FDA Class 3 ·Prosthesis, Hip, Constrained, Metal

System, Laser, Photodynamic Therapy

FDA classification

FDA Class 3 ·System, Laser, Photodynamic Therapy

Metal Cemented Constrained Femorotibial Knee Prosthesis

FDA classification

FDA Class 3 ·Metal Cemented Constrained Femorotibial Knee Prosthesis

Catheter, Percutaneous, Long Term, Intraspinal

FDA classification

FDA Class 3 ·Catheter, Percutaneous, Long Term, Intraspinal

Materials, Repair Or Replacement, Pacemaker

FDA classification

FDA Class 3 ·Materials, Repair Or Replacement, Pacemaker

Cooler, Prostatic

FDA classification

FDA Class 3 ·Cooler, Prostatic

Device, Antichoke, Suction

FDA classification

FDA Class 3 ·Device, Antichoke, Suction

Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

FDA classification

FDA Class 3 ·Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

Test System, For Drugs Of Abuse

FDA classification

FDA Class 3 ·Test System, For Drugs Of Abuse

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA classification

FDA Class 3 ·Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

Prosthesis, Arterial Graft, Bovine Carotid Artery

FDA classification

FDA Class 3 ·Prosthesis, Arterial Graft, Bovine Carotid Artery

Lenses, Soft Contact, Extended Wear

FDA classification

FDA Class 3 ·Lenses, Soft Contact, Extended Wear