Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC KAPPA 900/800 SERIES PACING SYSTEM

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·ORTHOPAK II BONE GROWTH STIMULATOR

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

FDA Pre-Market Approval

FDA Class 3 ·Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·GUARDIAN REAL-TIME CONTINUOUS GLUCOSE MONITORING SYSTEM

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Guardant360 CDx

Stent, Coronary

FDA classification

FDA Class 3 ·Stent, Coronary

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·BD Onclarity™ HPV Assay

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·cobas EGFR MUTATION TEST v2

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·cobas EGFR Mutation Test v2

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·BD Onclarity HPV Assay

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·BD Onclarity HPV Assay

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·BD Onclarity HPV Assay

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

Pediatric Esophageal Atresia Anastomosis Device

FDA classification

FDA Class 3 ·Pediatric Esophageal Atresia Anastomosis Device

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA classification

FDA Class 3 ·Prosthesis, Ankle, Uncemented, Non-Constrained

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