10,000 results · 36ms · Sources: EU EUDAMED, US FDA

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Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ONE PIECE POSTERIOR CHAMBER INTRAOCULAR LENS

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·HARMONY HIRESOLUTION BIONIC EAR SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·TAXUS LIBERTE' PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK APICAL LEFT VENTRICLE CONNECTOR

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Pre-Market Approval
FDA Class 3 ·VIBRANT SOUNDBRIDGE SYSTEM

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval
FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE VDD-2 LEAD

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·RX ACCULINK CAROTID STENT SYSTEM

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·APLIGRAF

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval
FDA Class 3 ·SALINE-FILLED BREAST IMPLANTS

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·INSYNC FAMILIES OF ICD & CONCERTO ICD

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·TEMPO PULSE GENERATORS

Controller, Closed-Loop Blood Glucose

FDA Pre-Market Approval
FDA Class 3 ·BIOSTATOR GLUCOSE CONTROLLER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·9F FREEZOR MAX SURGICAL CARDIAC CRYOABLATION DEVICE

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·PHYSIO STIM AND PHYSIO STIM LITE BONE GROWTH STIMULATORS

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·BIOLON TM

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC HALL ROTATABLE AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT

Digital Breast Tomosynthesis

FDA Pre-Market Approval
FDA Class 3 ·Mammomat Inspiration with Tomosynthesis Option / Mammomat Revelation with Tomosynthesis Option

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·KAPPA 600/700/800/900 AND ENPULSE FAMILIES OF PACEMAKERS