Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT Theon/RSR/Magna/Magna Ease Pericardial Aortic Bioprothesis / ThermaFix Tissue Process

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL/RSR/MAGNA/MAGNA EASE/MITRAL/MAGNA MITRAL AORTIC PERICARDIAL BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Perimount Bioprosthesis, Perimount Magna Aortic Bioprosthesis, Perimount Magna Ease Bioprosthesis, and Perimount Plus Bi

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROTHESIS,CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICA

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprosthesis 3000, with ThermaFix tissue process 3000TFX,Ease Per

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

FDA Pre-Market Approval

FDA Class 3 ·Et Control

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT, Plus, Theon, RSR, Magna,Magna Ease, Mega Mitral Pericardial Aortic Bioprosthesis with Ther

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards® PERIMOUNT® Pericardial/RSR/Magna/Magna Ease Aortic/ Plus/ Theon Pericardial Mitral Bioprosthesis wit

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

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT MITRA & AORTIC,THEON,RSR,THEON RSR,MAGNA,MAGNA EASE WITH& WITHOUT THERMAFEX TISSUE PROCESS

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Paragon CRT 100 (paflufocon D), Paragon CRT Dual Axis (paflufocon D) Rigid Gas Permeable Contact Lenses in Clear and Tin

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

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA classification

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

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

FDA classification

FDA Class 3 ·Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

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

FDA classification

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

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

Nitric Oxide Generator And Delivery System

FDA classification

FDA Class 3 ·Nitric Oxide Generator And Delivery System