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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·AID-B/BR AND VENTAK ICD

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·CONTAK RENEWAL TR, INVIVE, INTUA FAMILIES OF CRT-PS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VENTAK PRX, VENTAK MINI FAMILIES OF ICDS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·PULSAR, PULSAR MAX, DISCOVER, INSIGNIA, ALTRUA, INGENIO, ADVANTIO, VITALIO, FORMIO FAMILIES OF PACEMAKER

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·ADATO SIL-O1 5000 SILICONE OIL

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval
FDA Class 3 ·PRISMAFLEX TPE 2000 WITH PLASMAFILTER PF2000N

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·SILIKON 1000

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·LCS COMPLETE TOTAL KNEE SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·CERAMIC TRANSCEND HIP ARTICULATION SYSTEM

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval
FDA Class 3 ·TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM

Joint, Temporomandibular, Implant

FDA Pre-Market Approval
FDA Class 3 ·TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·STAARVISC II, SHELLGEL, COEASE SODIUM HYALURONATE

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·Misago RX Self-expanding Peripheral Stent

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·AMVISC & AMVISC PLUS

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

FDA Pre-Market Approval
FDA Class 3 ·IntellaNav Ol

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·LDR Spine Mobi-C® Cervical Disc Prosthesis

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·LDR Spine Mobi-C Cervical Disc Prosthesis

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VENTAK MINI IV (AICD)

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·Silikon 1000

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·OL 1000, OL 1000 SC, AND SPINALOGIC BONE GROWTH STIMULATORS