Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTMATE II

Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

FDA Pre-Market Approval

FDA Class 3 ·T-SPOT .TB TEST

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·QUICKSEAL SURESTAT ARTERIAL CLOSURE SYSTEM

Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

FDA Pre-Market Approval

FDA Class 3 ·T SPOT-TB TEST

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBS TEST SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS HBSAG TEST SYSTEM

Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

FDA Pre-Market Approval

FDA Class 3 ·T-SPOT TB TEST

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·SURESTAT ARTERIAL CLOSURE SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER LA-15 SYSTEM

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Evia HF, HF-T, Entovis HF, HF-T, Edora 8 HF-T, Enitra HF-T, Etrinsa 8 HF-T, Epyra 8 HF-T, Eluna 8 HF-T, Edora 8 HF-T QP,

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Evia HF/ HF-T; Entovis HF/ HF-T; Edora 8 HF-T; Enitra 8 HF-T; Enticos 8 HF-T; Evity 8 HF-T; Etrinsa 8 HF T; Epyra 8 HF-T

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Evia HF-T, Etrinsa 8 HF-T, Epyra 8 HF-T, Eluna 8 HF-T, Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Eni

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Evia HF-T, Etrinsa 8 HF-T, Epyra 8 HF-T, Eluna 8 HF-T, Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Eni

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Acticor 7 HF-T, Rivacor 7 HF -T, Rivacor 5 HF -T, Rivacor 3 HF-T, Acticor 7 HF-T QP, Rivacor 7 HF –T QP, Rivacor 5 HF –T

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·ENTOVIS HF(-T), EVIA HF (-T)

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·ENTOVIS HF (-T),EVIA HF(-T)

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Enitra 8 HF-T, Edora 8 HF-T QP, Edora 8 HF-T, Enitra 8 HF-T QP, Evity 8 HF-T, Evity 8 HF-T QP

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, Entico