Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval

FDA Class 3 ·PORT-A-CATH(R) INTRASPINAL IMPLANTABLE ACCESS SYST

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·iSert® Pre-loaded System; IPURE Pre-loaded System; PreVue Pre-loaded System

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Paragon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Paragon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·STAARVISC II & SHELLGEL SODIUM HYAURONATE

Pulse-Generator, Program Module

FDA Pre-Market Approval

FDA Class 3 ·MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Paragon Z CRT (tisilfocon A) and Paragon Z CRT Dual Axis (tisilfocon A) Rigid Gas Permeable Contact lenses in blue tint

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MICRO STENT II & GFX OVER-THE-WIRE CORONARY STENT SYSTEMS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UV-PMMA PCL'S

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·PARAGON CRT (PAFLUFOCON B), PARAGON CRT 100 (PAFLUFOCON D), PARAGON QUADRA RG (PAFLUFOCON B) AND PARAGON QUADRA RG 100..

Gastric Emptying Breath Test

FDA Pre-Market Approval

FDA Class 3 ·GASTRIC EMPTYING BREATH TEST (GEBT)

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDSTREAM AND CODMAN 3000 IMPLANTABLE INFUSION PUMP

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·Straumann Emdogain

Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents

FDA classification

FDA Class 3 ·Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA classification

FDA Class 3 ·Lens, Contact (Rigid Gas Permeable), Extended Wear

Nitric Oxide Generator And Delivery System

FDA Pre-Market Approval

FDA Class 3 ·LungFit PH

Nitric Oxide Generator And Delivery System

FDA classification

FDA Class 3 ·Nitric Oxide Generator And Delivery System

Analyzer, Gas, Nitrogen, Partial Pressure, Blood-Phase, Non-Indwelling

FDA classification

FDA Class 3 ·Analyzer, Gas, Nitrogen, Partial Pressure, Blood-Phase, Non-Indwelling