735 results · 28ms · Sources: EU EUDAMED, US FDA

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval
FDA Class 3 ·CARDIOGENESIS HOLMIUM TMR SYSTEM

Intravascular Radiation Delivery System

FDA Pre-Market Approval
FDA Class 3 ·NOVOSTE BETA-CATH SYSTEM

Glue, Surgical, Arteries

FDA Pre-Market Approval
FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval
FDA Class 3 ·PEARL 8.0 HANDPIECE FOR TRANSMYOCARDIAL REVASCULARIZATION (TMR) WITH THE CARDIOGENESIS HOLMIUM: YAG LASER SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·TEGRESS URETHRAL IMPLANT

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ON-X PROSTHETIC HEART VALVE AND ON-X ASCENDING AORTIC PROSTHESIS (ONXAAP)

System, Hemodynamic, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CardioMEMS patient and hospital electronics

Glue, Surgical, Arteries

FDA Pre-Market Approval
FDA Class 3 ·BioGlue Surgical Adhesive

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·On-X Prosthetic Heart Valve

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

Glue, Surgical, Arteries

FDA Pre-Market Approval
FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE

Glue, Surgical, Arteries

FDA Pre-Market Approval
FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·HYDROCURVE

Intravascular Radiation Delivery System

FDA Pre-Market Approval
FDA Class 3 ·NOVOSTE(TM) BETA-CATH(TM) SYSTEM

Glue, Surgical, Arteries

FDA Pre-Market Approval
FDA Class 3 ·BioGlue Surgical Adhesive

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·On-X Prosthetic Heart Valve, Model Onxa

Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

FDA Pre-Market Approval
FDA Class 3 ·Cartiva Synthetic Cartilage Implant

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ON-X PROSTHETIC HEART VALVE