723 results · 22ms · Sources: EU EUDAMED, US FDA

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP, Impella RP with Smart Assist, Impella $.0/LD

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RESTYLANE INJECTABLE GEL

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·HYLAFORM PLUS (HYLAN B GEL)

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RESTYLANE INJECTABLE GEL

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Belotero Balance (+) Lidocaine

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·HYDRELLE

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·COBRA PzF NanoCoated Coronary Stent System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·PERLANE INJECTABLE GEL

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·Integre Dermal Regeneration Template

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·THE MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PLUS MITRAL PERICARDIAL BIOPROSTHESIS MODEL 6900PTFX

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·JUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·REVANESSE ULTRA

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval
FDA Class 3 ·Scandinavian Total Ankle Replacement (STAR Ankle)

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·ARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT DERMAL FILLER

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VENTAK AV/VR

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·COBRA PzF NanoCoated Coronary Stent System

Transcatheter Septal Occluder (Atrial)

FDA Pre-Market Approval
FDA Class 3 ·Occlutech ASD Occluder, Occlutech Pistol Pusher (OPP), Occlutech ASD Occluder Procedure Pack

Transcatheter Septal Occluder (Atrial)

FDA Pre-Market Approval
FDA Class 3 ·Occlutech® ASD Occluder and Occlutech® Pistol Pusher

Transcatheter Septal Occluder (Atrial)

FDA Pre-Market Approval
FDA Class 3 ·Occlutech® ASD Occluder and Occlutech® Pistol Pusher