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

FDA Pre-Market Approval

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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·O2 OPTIX (LOTRAFILCON B) AND NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR

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

FDA Pre-Market Approval

FDA Class 3 ·Guardant360 CDx

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

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·APTIMA HPV 16 18/45 GENOTYPE ASSAY

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK LEAD SYSTEM

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA classification

FDA Class 3 ·Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

Alfapump System

FDA classification

FDA Class 3 ·Alfapump System

Adhesive, Denture, Polyacrylamide Polymer (Modified Cationic)

FDA classification

FDA Class 3 ·Adhesive, Denture, Polyacrylamide Polymer (Modified Cationic)

Resin, Root Canal Filling Containing Chloroform

FDA classification

FDA Class 3 ·Resin, Root Canal Filling Containing Chloroform

Sterilizer, Endodontic Dry Heat

FDA classification

FDA Class 3 ·Sterilizer, Endodontic Dry Heat

Material, Dressing, Surgical, Polylactic Acid

FDA classification

FDA Class 3 ·Material, Dressing, Surgical, Polylactic Acid

Interarticular Disc Prosthesis (Interpositional Implant)

FDA classification

FDA Class 3 ·Interarticular Disc Prosthesis (Interpositional Implant)

Biologic Material, Dental

FDA classification

FDA Class 3 ·Biologic Material, Dental

Sterilizer, Glass Bead

FDA classification

FDA Class 3 ·Sterilizer, Glass Bead

Glenoid Fossa Prosthesis

FDA classification

FDA Class 3 ·Glenoid Fossa Prosthesis

Joint, Temporomandibular, Implant

FDA classification

FDA Class 3 ·Joint, Temporomandibular, Implant

Paste, Injectable For Vocal Cord Augmentation

FDA classification

FDA Class 3 ·Paste, Injectable For Vocal Cord Augmentation