Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HAV TOTAL ASSAY, ADVIA CENTAUR HAV TOTAL QUALITY CONTROL MATERIALS

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·Multifunctional Ablation Generator (MAG)

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·Multifunctional Ablation Generator (MAG)

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·9EPANOSTIKA(TM) ANTI-HAV IGM

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Prometra Programmable Infusion Pump System

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PHYLAX AV ICD SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) LEGEND PLUS(TM) PULSE GENERATOR

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA Pre-Market Approval

FDA Class 3 ·AAV5 DetectCDx®

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA Pre-Market Approval

FDA Class 3 ·AAV5 DetectCDx

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·Fluency® Plus Endovascular Stent Graft

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·FLAIR ENDOVASCULAR STENT GRAFT