3,089 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Aspiration Therapy System
FDA Pre-Market Approval
FDA Class 3
·AspireAssist
System, Hemodynamic, Implantable
FDA Pre-Market Approval
FDA Class 3
·CardioMEMS HF System
Agent, Bulking, Injectable For Gastro-Urology Use
FDA Pre-Market Approval
FDA Class 3
·COAPTITE
Sealant, Polymerizing
FDA Pre-Market Approval
FDA Class 3
·NEOMEND PROGEL PLEURAL AIR LEAK SEALANT
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·CURRENT + DEVICES & CURRENT ACCEL DEVICES
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·NATRELLE SILICONE-FILLED BREAST IMPLANT
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·EPi-Sense Guided Coagulation System
Valve, Pulmonary
FDA Pre-Market Approval
FDA Class 3
·Zephyr Valve Reigstry (ZEVR)
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·TACHYCARDIA DEFIBRILLATOR DEVICES
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·Biosense Webster NaviStar ThermoCool Catheter
Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·Organ Care System (OCS) Lung System
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 3
·OL1000/OL1000 SC AND SPINALOGIC BONE BROWTH STIMULATORS
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·ON-X (R) PROSTHETIC HEART VALVE, ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE, ON-X AORTIC PROSTHETIC HEART VALVE WITH A
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Elecsys HBsAg II
System, Oxygen, Aqueous
FDA Pre-Market Approval
FDA Class 3
·TherOx Downstream System
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·AFX ENDOVASCULAR AAA SYSTEM
System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
FDA Pre-Market Approval
FDA Class 3
·COLOGUARD
Tricuspid Valve Repair Device, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·TriClip G4 System
Sealant, Polymerizing
FDA Pre-Market Approval
FDA Class 3
·COSEAL SURGICAL SEALANT
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·R3 DELTA CERAMIC HIP SYSTEM