Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·AEGEA Vapor System, Aegea Vapor Probe Procedure Kit, Aegea Vapor Generator and Aegea Vapor Generator Accessory Kit

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Mara Water Vapor System

Fluid, Hysteroscopy

FDA Pre-Market Approval

FDA Class 3 ·HYSKON (32% DEXTRAN 70)

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·AEGEA Water Vapor Ablation System

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Mara Vapor System

S80 IMPLANTABLE CARDIAC PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

STYLET INTRODUCER FUNNEL

FDA 510(k)

FDA Class 3 ·Cardiovascular

QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR

FDA 510(k)

FDA Class 3 ·Cardiovascular

IMPLANTABLE ELECTRODE LEAD 030-271 USING POLYURETH

FDA 510(k)

FDA Class 3 ·Cardiovascular

IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS

FDA 510(k)

FDA Class 3 ·Cardiovascular

IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLE

FDA 510(k)

FDA Class 3 ·Cardiovascular

IMPLANTABLE ELECTRODE LEAD, MODEL 030-400

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 1740 PERSONAL POCKET PROGRAMMER

FDA 510(k)

FDA Class 3 ·Cardiovascular

DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES

FDA 510(k)

FDA Class 3 ·Cardiovascular

RESUBMISSION OF MODEL 030-437 IMPLANT. ELECTRODE

FDA 510(k)

FDA Class 3 ·Cardiovascular

IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW

FDA 510(k)

FDA Class 3 ·Cardiovascular

DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P

FDA 510(k)

FDA Class 3 ·Cardiovascular