Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIK LOAD

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·CARDIOSEAL SEPTAL OCCLUSION SYSTEM W/QWIK LOAD

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·CARDIOSEAL SEPTAL OCCLUSION SYSTEM

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·STARFLEX SEPTAL OCCLUSION SYSTEM

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIK LOAD

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QUICK LOAD

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·CARDIOSEAL SEPTAL OCCULUSION SYSTEM WITH QWIK LOAD

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CardioMEMS HF System

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION UTERINE CRYOABLATION THERAPY SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·MODEL 8005 PUMP SYSTEM (CIRCUCOOL PUMP), MODEL M00480050

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·CollaCote(TM), CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·SEPRAFILM BIORESORBABLE MEMBRANE

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Helistat and Helitene Absorbable Collagen Hemostatic Agents

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators and Accessories

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic- Microfibrillar Form