10,000 results · 37ms · Sources: EU EUDAMED, US FDA

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·cobas HBV Test

Femtosecond Laser System For Refractive Correction

FDA Pre-Market Approval
FDA Class 3 ·VisuMax Femtosecond Laser

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

FDA Pre-Market Approval
FDA Class 3 ·Light Adjustable Lens, Light Delivery Device

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval
FDA Class 3 ·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Precision Spional Cord Stimulator (SCS) Systems

Drug-Eluting Sinus Stent

FDA Pre-Market Approval
FDA Class 3 ·Mometasone Furoate Container Closure System

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

FDA Pre-Market Approval
FDA Class 3 ·Oncomine Dx Target Test

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Guardian Connect System

Ablation Catheter, Renal Denervation

FDA Pre-Market Approval
FDA Class 3 ·Paradise Ultrasound Renal Denervation System, Paradise Cartridge, Paradise Generator

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL 304 (ULTRA C-LOOP)

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·Obalon Touch Dispenser

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval
FDA Class 3 ·TRULIGN TORIC WEB BASED TORIC CALCULATOR

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·VASCULAR CLOSURE SYSTEMS

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·MODEL 3510 PROGRAMMER AND MODEL 3134 EXTERNAL VIDEO CABLE

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·CONNECTOR-M1

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK MODIFIED ORIFICE PORCINE BIOPROSTHETIC HEART VALVE

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·Aptima HPV 16 18/45 Genotype Assay

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·Acess AFP Reagents on the Access Immunoassay Systems

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas BRAF V600 Mutation Test

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·X-70 SOFT CONTACT LENS