Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·iStent inject Trabecular Micro-Bypass System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (senofilcon A) Brand Contact Lenses

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL

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

FDA Pre-Market Approval

FDA Class 3 ·Guardant360 CDx

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval

FDA Class 3 ·RxSight Light Adjustable Lens (LAL) and light Delivery Device (LDD)

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

FDA Pre-Market Approval

FDA Class 3 ·Vysis CLL FISH Probe Kit

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL PC-36CNB (TIER A)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof Intraocular Lenses

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·PERMALENS EXTENDED WEAR CONTACT LENS

Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

FDA classification

FDA Class 3 ·Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

Filler, Bone Void, Synthetic Peptide

FDA classification

FDA Class 3 ·Filler, Bone Void, Synthetic Peptide

Gastric Emptying Breath Test

FDA classification

FDA Class 3 ·Gastric Emptying Breath Test

Pediatric Esophageal Atresia Anastomosis Device

FDA classification

FDA Class 3 ·Pediatric Esophageal Atresia Anastomosis Device

Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

FDA classification

FDA Class 3 ·Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

FDA classification

FDA Class 3 ·Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

Generator, Pulsatile Flow, Cardiopulmonary Bypass

FDA classification

FDA Class 3 ·Generator, Pulsatile Flow, Cardiopulmonary Bypass

Lens, Intraocular, Toric Optics

FDA classification

FDA Class 3 ·Lens, Intraocular, Toric Optics

Lenses, Soft Contact, Extended Wear

FDA classification

FDA Class 3 ·Lenses, Soft Contact, Extended Wear

Fluid, Intraocular

FDA classification

FDA Class 3 ·Fluid, Intraocular

Aid, Surgical, Viscoelastic

FDA classification

FDA Class 3 ·Aid, Surgical, Viscoelastic