Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY COOL PATH ABLATION CATHETER

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-MAK-2 PLUS

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE 2000 AFP

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER 1-PC AND 3-PC INTRAOCULAR LENSES

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·BJORK-SHILEY CARDIAC VALVE

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL AA-4203F SINGLE PIECE IOL

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·VISIAN IMPLANTABLE COLLAMER LENS

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·EVO Visian Implantable Collamer Lens for Myopia (VICMO), EVO Visian Toric Implantable Collamer Lens for Myopia (VTICMO),

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

FDA Pre-Market Approval

FDA Class 3 ·DIASORIN ETI-MAK-2 PLUS

System, Oxygen, Aqueous

FDA Pre-Market Approval

FDA Class 3 ·TherOx Downstream System

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·INFANT STAR HIGH FREQUENCY VENTILATOR

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY COOL PATH ABLATION CATHETER

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

FDA Pre-Market Approval

FDA Class 3 ·DIASORIN ETI-EBK PLUS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Therapy Cool Path, Safire BLU, Safire BLU SP, and Therapy Cool Path SP Ablation Catheters

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·Visian Implantable Collamer Lens (ICL)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Collamer UV Absorbing Posterior Chamber Intraocular Lens

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-EBK PLUS

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL IMPLANTABLE COLLAMER LENS (VISION ICL)

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

FDA Pre-Market Approval

FDA Class 3 ·LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus