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

Kit, Chemical Snake-Bite

FDA classification

FDA Class 3 ·Kit, Chemical Snake-Bite

Catheter, Percutaneous, Long Term, Intraspinal

FDA classification

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

Pump, Drug Administration, Closed Loop

FDA classification

FDA Class 3 ·Pump, Drug Administration, Closed Loop

Controller, Closed-Loop, Blood-Pressure

FDA classification

FDA Class 3 ·Controller, Closed-Loop, Blood-Pressure

Pump, Infusion, Implanted, Programmable

FDA classification

FDA Class 3 ·Pump, Infusion, Implanted, Programmable

Device, Peritoneal Access, Subcutaneous, Implanted

FDA classification

FDA Class 3 ·Device, Peritoneal Access, Subcutaneous, Implanted

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

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent Kit, ARCHITECT HBsAg NEXT Qualit

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Guardian Connect system

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·OBALON BALLOON SYSTEM