Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 6836 Y CONNECTOR (AID B/BR)

Stent, Iliac Vein

FDA Pre-Market Approval

FDA Class 3 ·Abre™ Venous Self-expanding Stent Systems Self-expanding Stent System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·AID (R) B/BR HIGH VOLTAGE CABLES FOR ECD SYSTEMS

Occluder, Internal Vessel, Temporary

FDA Pre-Market Approval

FDA Class 3 ·LEGOO

Barrier, Adhesion, Cardiovascular

FDA Pre-Market Approval

FDA Class 3 ·REPEL-CV BIORESORBABLE ADHESION BARRIER

Barrier, Adhesion, Cardiovascular

FDA Pre-Market Approval

FDA Class 3 ·REPEL-CV

Occluder, Internal Vessel, Temporary

FDA Pre-Market Approval

FDA Class 3 ·LEGOO ENDOVASCULAR OCCLUSION GEL

Occluder, Internal Vessel, Temporary

FDA Pre-Market Approval

FDA Class 3 ·LEGOO ENDOVASCULAR OCCLUDER

Occluder, Internal Vessel, Temporary

FDA Pre-Market Approval

FDA Class 3 ·LEGOO

Barrier, Adhesion, Cardiovascular

FDA Pre-Market Approval

FDA Class 3 ·REPEL-CV BIORESORBABLE ADHESION BARRIER

Occluder, Internal Vessel, Temporary

FDA Pre-Market Approval

FDA Class 3 ·LEGOO

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG

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

FDA classification

FDA Class 3 ·System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATOR

DJP UNIPOLAR

FDA 510(k)

FDA Class 3 ·Cardiovascular

EKG TRANSMITTER MODEL 5134

FDA 510(k)

FDA Class 3 ·Cardiovascular

HEARTSTART 1000S

FDA 510(k)

FDA Class 3 ·Cardiovascular

LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP

FDA 510(k)

FDA Class 3 ·Cardiovascular

EDP-20 PACEMAKER

FDA 510(k)

FDA Class 3 ·Cardiovascular

AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP

FDA 510(k)

FDA Class 3 ·Cardiovascular