Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·CollaPlug Absorbable Collagen Wound Dressing For Dental Surgery

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FAMILY/FLOUR/SYRINGEAVITENE/CAST MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH)

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Cerene Cryotherapy Device (Model Number FGS-7000)

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·CONTINUOUS GLUCOSE MONITORING SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·sentus QP LV Lead

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Algovita Spinal Cord Stimulation System

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·EP Passion Initiative

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·STINGER/STRINGER S/STINGER M/STINGER SM/SCORPION/SCORPION M/SCORPION *2/SCORPION *2 M ABLATION CATHETERS

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS Total Knee System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC SYNCHROMED INFUSION SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Minerva ES Endometrial Ablation System

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·MAMMOMAT INSPIRATION TOMOSYNTHESIS OPTION

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) NON-WOVEN WEB/ENDOAVITENE

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MMR RxDx Panel

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MMR RxDx Panel

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MMR RxDx Panel

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvéderm® Volbella™ XC

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·CGMS IPRO SYSTEM

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·MODEL 5071 LEAD