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

FDA Pre-Market Approval

FDA Class 3 ·ETI-AB-EBK PLUS KIT

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY ABLATION CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Therapy Ablation Catheter including Bi-Directional catheter and Therapy 4mm Thermistor Ablation Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR ANTI-HBS2 MASTER CURVE MATERIALS

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER

System, Oxygen, Aqueous

FDA Pre-Market Approval

FDA Class 3 ·TherOx Downstream System

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

FDA Pre-Market Approval

FDA Class 3 ·THERAPY DUAL 8 CARDIAC ABLATION SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-MAK-2 PLUS KIT

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL COLLAMER INTRAOCULAR LENSES

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY CARDIAC ABLATION CATHETER

Intraocular Lens

FDA Pre-Market Approval

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

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·EVO/EVO+ VISIAN® Implantable Collamer® Lenses

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

FDA Pre-Market Approval

FDA Class 3 ·THERAPY DUAL 8 ABLATION CATHETERS

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR ANTI-HBS2 (AL-BS2) ASSAY

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·IBI THERAPY ABLATION CATHETERS

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·NELLCOR PURITAN BENNETT INFANT STAR HIGH FREQUENCY VENTILATOR

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ELASTIC UVA PC IOL

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ELASTIMIDE(TM) SILICONE MODIFIED C-LOOP POST. CHAM