Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·VISIAN ICL (IMPLANTABLE COLLAMER LENS)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL COLLAMER INTRAOCULAR LENSES

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-AB-AUK PLUS ASSAY

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·BJORK-SHILEY CARDIAC VALVE

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·CELT ACD PLUS Vascular Closure Device

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Collamer Intraocular Lens - Alternat Environmental Monitoring Provider

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

FDA Pre-Market Approval

FDA Class 3 ·SAFIRE BLU AND THERAPY COOL PATH BI-DIRECTIONAL ABLATION CATHETERS

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-CORE-IGMK PLUS KIT

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·MLI 1000 ND:YAG OP LASER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY COOL PATH CATHETER(6 HOLE IRRIGATED) AND BI-DIRECTIONAL, SAFIRE BLU (6HOLE IRRIGATED) SAFIRE BLUE SP AND THERAPY

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL COLLAMER INTRAOCULAR LENSES

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-MAK-2 PLUS and HBsAg Confirmatory Test Assays

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-AB-AUK PLUS Assay

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

FDA Pre-Market Approval

FDA Class 3 ·THERAPY DUAL 8 CATHETER,THERAPY 8MM THERMISTOR ABLATION CATHETER, SAFIRE TX, AND ASSOCIATED CABLES

System, Oxygen, Aqueous

FDA Pre-Market Approval

FDA Class 3 ·TherOx Downstream System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL COLLAMER INTRAOCULAR LENSES

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

FDA Pre-Market Approval

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

System, Oxygen, Aqueous

FDA Pre-Market Approval

FDA Class 3 ·TherOx Downstream Console

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

FDA Pre-Market Approval

FDA Class 3 ·THERAPY DUAL 8, THERAPY & SAFIRE TX ABLATION CATHETERS