10,000 results · 114ms · Sources: EU EUDAMED, US FDA

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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

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·EXPRESS MONORAIL AND OTW CORONARY STENT SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·PARADYM CRT-D 8750,PARADYM RF CRT-D 9750 (ZL101), PARADYM RF CRT-D 9750 (ZL 102) AND INTENSIA CRT-D

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·HELISTAT HELITENSE ABSORBABLE COLLLAGENHEMOSTATIC AGENT MICROFIBRILLAR FORM

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·X-STOP INTERSPINOUS PROCESS DECOMPRESSION (IPD) SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Spinal Cord Stimulation (SCS)

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval
FDA Class 3 ·VENTANA ALK (D5F3) CDX ASSAY

Prosthesis, Breast, Inflatable, Internal, Saline

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

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MitraClip™ G4 Clip Delivery System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·ARROW INTERNATIONAL MODEL 3000/3000-16/3000-50 IMPLANTABLE INFUSION PUMPS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EASYTRAK AND ACUITY SPIRAL LEAD SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·OPEN PIVOT AORTIC VALVED GRAFT

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·Tryton Side Branch Stent

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ENDOTEK RELIANCE DF1/IS-1 AND RELIANCE 4-SITE LEAD FAMILIES