Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK II BIOPROSTHESIS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·COROX OTW STEROID LV LEAD MONITORING (COSMO)

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·INSTAT ABSORBABLE COLLAGEN HEMOSTAT

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

FDA Pre-Market Approval

FDA Class 3 ·Corox OTW BP/OTW-S BP; Corox OTW-L BP/ProMRI OTW-L BP; Corox ProMRI OTW BP/ProMRI OTW-SBP; Sentus ProMRI OTW QP S/ProMRI

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·PHYSIO-STIM MODELS 3202, 3302, 3313, 3314, 3315 AND SPINAL-STIM LODEL 2212

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-MAK-2 PLUS ASSAY

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOFINITY

Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation

FDA Pre-Market Approval

FDA Class 3 ·Vivistim® System

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·PROTEGO FAMILY OF ICD LEADS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MYCARELINK PATIENT MONITOR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE VDD 2 LEAD, SERVICE KIT-PACEMAKER REPAIR KIT, VITATRON BRILLIANT S+ VDD LEAD

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix Lead

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 2.5, CP, and CP with SmartAssist

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS, REVEAL PLUS & BOSS

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·ARISTA AH ABSORBABLE HEMOSTAT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Protego TD, SD 75/18, 65/18, 65/16 and SD 60/16 Protego T 65, and S 75, 65, 60 Plexa S 60, PLexa SD 60/16, Plexa ProMRI

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·LIAISON QuantiFERON - TB Gold Plus and LIAISON Control QuantiFERON - TB Gold Plus