329 results · 18ms · Sources: EU EUDAMED, US FDA

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·HALL (TM) EASY-FIT PROSTHETIC HEART VALVE

Joint, Temporomandibular, Implant

FDA Pre-Market Approval
FDA Class 3 ·TMJ Concepts Patient-Fitted Temporomandibular Joint (TMJ) st

Joint, Temporomandibular, Implant

FDA Pre-Market Approval
FDA Class 3 ·TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC HALL PROSTHETIC HEART VALVE /HALL EASY FIT

Joint, Temporomandibular, Implant

FDA Pre-Market Approval
FDA Class 3 ·TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·PRARDIGM REAL-TIME INSULIN PUMPS AND GUARDIAN REAL-TIME MONITOR

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC HALL PROSTHETIC HEART VALVE/EASY-FIT/AORTIC VALVED CONDUIT/COLLAGEN IMPREGNATED CONDUIT/ROTATABLE AORTIC

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RADIESSE INJECTABLE IMPLANT

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RADIESSE INJECTABLE IMPLANT

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RADIESSE INJECTABLE IMPLANT FOR SUB-DERMAL IMPLANTATION FOR RESTORARION AND OR/ CORRECTION OF THE SIGNS OF FACIAL FAT LO

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RADIESSE INJECTABLE IMPLANT FOR SUB-DERMAL IMPLANTATION FOR RESTORATION AND OR CORRECTION FOR THE SIGNS OF FACIAL FAT LO

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EVERA S DR, EVERA S VR, EVERA XT DR

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscoelastic System, and DISCOVISC™ Ophthalmic Viscosurgic

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SM-1, CR-1, & GR-1 IOLS