10,000 results · 44ms · Sources: EU EUDAMED, US FDA

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC KAPPA 900/800 SERIES PLUSE GENERATORS

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

FDA Pre-Market Approval
FDA Class 3 ·STELKAST SURPASS ACETABULAR SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·ABIOMED BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·LATITUDE COMMUNICATOR SOFTWARE & SYSTEM SOFTWARE MODELS: 6482 AND 6488

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·LUMAX 540 VR-T DX ICD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·DELTA PACEMAKER SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·Integrity Coronary Stent System RX and OTW

Aortic Stent

FDA Pre-Market Approval
FDA Class 3 ·Minima Stent System

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·BARD TEGRESS URETHRAL IMPLANT

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·PROSTATRON

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ENTRUST ICD AND THE CARDIOSIGHT READER

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·PHILOS FAMILY OF PULSE GENERATORS

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·CORDIS PALMAZ BALLOON EXPANDABLE STENTS

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

FDA Pre-Market Approval
FDA Class 3 ·LCS TOTAL KNEE SYSTEM ¿ MBT REVISION TIBIAL TRAYS

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·INTERSTIM THERAPY SYSTEMS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL 304 (ULTRA C-LOOP)

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RESTYLANE-L

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·PMMA ANTERIOR CHAMBER IOLS

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval
FDA Class 3 ·GAMBRO PLASMAFILTER, PF2000N

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·AUTIMA(TM) MODEL 2251 & MODEL 2600