Aortic Valve, Prosthesis, Percutaneously Delivered

FDA classification

FDA Class 3 ·Aortic Valve, Prosthesis, Percutaneously Delivered

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·ACUVUE 2 COLORS BRAND (ETAFILCON A) CONTACT LENS WITH UV BLOCKER

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne Liquid CDx (F1 Liquid CDx)

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne Liquid CDx

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ACS AND ACS RX MULTI-LINK CORONARY STENT SYSTEMS

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) WAVESCAN WAVEFRONT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·MONOLISA ANTI-HBS EIA

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER

Prostrate Cancer Genes Nucleic Acid Amplification Test System

FDA Pre-Market Approval

FDA Class 3 ·PROGENSA PCA3 ASSAY

Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

FDA Pre-Market Approval

FDA Class 3 ·AvertD and AvertD Buccal Sample Collection Kit

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR ROTALINK PLUS ROTATIONAL ANGIOPLASTY SYSTEM

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·Cologuard

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·NIDEK EC-5000 EXCIMER LASER SYSTEM (PARK)

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE 2000 XPI ANTI-HBC IMG

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·myChoice HRD CDx

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·THUNDER HIGH SCAFFORDING OVER-THE-WIRE AND RAPID EXCHANGE SAPHENOUS VEIN GRAFT STENT SYSTEMS

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·Inspire Upper Airway Stimulation

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

FDA Pre-Market Approval

FDA Class 3 ·Oncomine Dx Express Test