10,000 results · 119ms · Sources: EU EUDAMED, US FDA

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval
FDA Class 3 ·GEM 21S GROWTH FACTOR ENHANCED MATRIX RHPDGF-BB COMPONENT

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ION (TAXUS ELEMENT) CORONARY STENT SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CT LUCIA 202 and CT LUCIA 602 intraocular lenses

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·7F FREEZOR CARDIAC CRYOABLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEM

System, Laser, Fiber Optic, Photodynamic Therapy

FDA Pre-Market Approval
FDA Class 3 ·OPTIGUIDE(TM) FIBER OPTIC DIFFUSER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Azure S DR MRI IPG, Azure S SR MRI IPG, Azure XT DR MRI IPG, Azure XT SR MRI IPG

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·COLLASTAR INSTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT MICROFIBRILLAR

System, Hemodynamic, Implantable

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

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

FDA Pre-Market Approval
FDA Class 3 ·IntellaNav OI, and IntellaNav MiFi OI

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·PARADYM (VR/DR) 8750, PARADYM RF (VR/DR) 9750(ZL101),PARADYM RF (VR/DR) 9750 (ZL102),INTENSIA (VR/DR)

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

FDA Pre-Market Approval
FDA Class 3 ·DIMENSION VISTA FPSA ASSAY

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·VERIFLEX (LIBERTE) CORONARY STENT SYSTEM

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Alinity m HBV Assay

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·IMPELLA CP Systems

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·SYNVISC HYLAN G-F 20

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HEARTWARE VENTRICULAR ASSIST SYSTEM

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval
FDA Class 3 ·ELCA Catheters