10,000 results · 25ms · Sources: EU EUDAMED, US FDA

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·Mentor MemoryShape Breast Implants

System, Hemodynamic, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CardioMEMS HF System

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS, MITRAL BIOPROSTHESIS,; BIOPROSTHESIS VALVED CONDUIT; DURAFLEX LOW PRES

Intravascular Radiation Delivery System

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

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Assurity MRI, Endurity MRI

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 670G System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Skinvive™ by Juvéderm®

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·Vertiflex Instrument Platform (VIP) Kit

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·SKINVIVE™ by Juvederm

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

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

Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

FDA Pre-Market Approval
FDA Class 3 ·Cartiva SCI Implant

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·META-MV,PACING SYSTEM

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT AV DCB

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·Chilli Cooled RF Ablation System

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODELS PC10 & PC21

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·POSTERIOR CHAMBER INTROCULAR LENSES

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SINGLE-PIECE AND THREE PIECE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·DERMAGRAFT