System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·ALERE NMP22 BLADDERCHEK TEST

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·MODEL SPF-60 SPINAL FUSION STIMULATOR

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval

FDA Class 3 ·X-STOP LTOS

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval

FDA Class 3 ·RxSight Light Adjustable Lens and Light Delivery Device

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·Selenia Dimensions 3D System High Resolution Tomosynthesis

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·DEFLUX INJECTABLE GEL

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval

FDA Class 3 ·TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·SPINAL-STIM SPINAL FUSION SYSTEM

Microspheres Radionuclide

FDA Pre-Market Approval

FDA Class 3 ·SIR-SPHERES MICROSPHERES

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA TREMOR CONTROL THEREAPY SYSTEM

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Helistat Absorable Collagen Hemostatic Agent and Helitene Absorable Collagen Hemostatic Agent Fibrillar Form

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RHA 2, RHA 3, RHA 4

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RIATA LEAD MODELS 1580, 1581 AND 1582; RIATA, RIATA ST AND RIATA ST OPTIM LEAD FAMILIES

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·GEM 21S (GROWTH-FACTOR ENHANCED MATRIX

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Collastat Absorable Collagen Hemostatic Sponge and Collastat Absorable Collagen Hemostatic Agent Microfibrillar Form

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) HALL PROSTHETIC HEART VALVE AND VALVED CONDUITS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK VISION & MULTI-LINK MINI VISION CORONARY STENT SYSTEM

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·SUPARTZ FX

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY SYSTEM