Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Livewire TC Ablation Catheter (Livewire TC)

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

FDA Pre-Market Approval

FDA Class 3 ·Alinity i Anti-HBc IgM Reagent Kit (2x100 Tests)

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval

FDA Class 3 ·Floseal Hemostatic Matrix, RT5

Sensor, Electro-Optical (For Cervical Cancer)

FDA Pre-Market Approval

FDA Class 3 ·LUMA CERVICAL IMAGING SYSTEM

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·Coseal Surgical Sealant; Coseal Spray Set

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·FLOSEAL HEMOSTATIC MATRIX

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·COSEAL SURGICAL SEALANT

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval

FDA Class 3 ·Floseal Hemostatic Matrix

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Pro Flash Glucose Monitoring System

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBSAG/CONFIRMATORY

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M / Alinity i Anti-HBc IgM

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

FDA Pre-Market Approval

FDA Class 3 ·Alinity i HBsAg Qualitative II

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWARE TC ABLATION CATHETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC CARDIAC ABLATION SYSTEM-CABLE 10X ETO REUSE/RESTERILIZATION, NEW EXTENSION CABLE

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC CARDIAC ABLATION CATHETER