1,575 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·ANGIO-SEAL(TM)[1] HEMOSTATIC PUNCTURE CLOSURE DEVICE
Agent, Bulking, Injectable For Gastro-Urology Use
FDA Pre-Market Approval
FDA Class 3
·CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CAPENTIER EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·MYNXGRIP VASCULAR CLOSURE DEVICE
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·M5 MYNX VASCULAR CLOSURE DEVICE
Lens, Multifocal Intraocular
FDA Pre-Market Approval
FDA Class 3
·ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·VASOSEAL ES DEVICE
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·SUPARTZ FX
Lens, Multifocal Intraocular
FDA Pre-Market Approval
FDA Class 3
·ACRYSOF IQ RESTOR +2.5 D MULTIFOCAL INTRAOCULAR LENS
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·VASOSEAL ELITE VHD/ES DEVICE
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR HBEAG ASSAY AND QUALITY CONTROL MATERIAL
Imager, Breast, Electrical Impedance
FDA Pre-Market Approval
FDA Class 3
·T-SCAN 2000
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·TACHOS DR ATRIAL TX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ICD SYSTEM
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·CLOSER XL SUTURE MEDIATED CLOSURE (SMC) SYSTEM
Lens, Multifocal Intraocular
FDA Pre-Market Approval
FDA Class 3
·TECNIS MULTIFOCAL 1-PIECE INTRAOCULAR LENS (IOL)
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·EUFLEXXA 1% SODIUM HYALURONATE
Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
FDA Pre-Market Approval
FDA Class 3
·EXABLATE
Device, Impotence, Mechanical/Hydraulic
FDA Pre-Market Approval
FDA Class 3
·MENTOR TITAN INFLATABLE PENILE PROSTHESIS