3,277 results · 26ms · Sources: EU EUDAMED, US FDA

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·CraniSeal Dural Sealant

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval
FDA Class 3 ·i-FACTOR® Peptide Enhanced Bone Graft

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval
FDA Class 3 ·i-FACTOR™ Peptide Enhanced Bone Graft

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·NIRXCELL COCR CORONARY STENT ON RX SYSTEM

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·TARGIS SYSTEM

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·TARGIS TARGETED TRANSURETHRAL THERMOABLATION SYSTEM (TARGIS SYSTEM): NEW POUCH SEALER

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·BD 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·EluNIR Ridaforolimus Eluting Coronary Stent System

Hybrid Stent Graft, Thoracic Aortic Lesion Treatment

FDA Pre-Market Approval
FDA Class 3 ·Thoraflex™ Hybrid

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval
FDA Class 3 ·i-FACTOR Peptide Enhanced Bone Graft

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·CELT ACD VASCULAR CLOSURE DEVICE

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CHANGE IN MANUFACTURING PROCESS TO CLEAN EYE

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·TRIVASCULAR, INC. OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·BVI 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·UROLOGIX TARGIS SYSTEM

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Pre-Market Approval
FDA Class 3 ·MAXUM SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·AFX STAND-ALONE LIMB EXTENSION DELIVERY SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·AFX Endovascular AAA System

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·SpineSeal Spine Sealant