449 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·FreeStyle Libre Pro Flash Glucose Monitoring System
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·Accessory, Stabilizer
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·FINELINE® II Sterox, FINELINE® II EZ Sterox, ACC SUP STABLZR 6220 US, ACC SUP STABLZR 6221 US
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ANTI-HBS IMMULITE ASSAY
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·VARIOUS DEFENDER & ALTO ICDS MODELS & ORCHESTRA PROGRAMMER
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·VARIOUS MODELS OF RATE-RESPONSIVE PACEMAKERS
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·ANGIOJET RHEDOLYTIC THROMBECTOMY SYSTEM CORONARY USE
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·CHORUS & OPUS RATE-RESPONSIVE PACEMAKERS
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·MOSAIC PORCINE BIOPROSTHESIS
Stent, Central Venous
FDA Pre-Market Approval
FDA Class 3
·Wallstent Venous Endoprosthesis with Unistep Plus Delivery System
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·ANCURE TUBE AND BIFURCATED ENDOGRAFT SYSTEM
Shunt, Portosystemic, Endoprosthesis
FDA Pre-Market Approval
FDA Class 3
·Wallstent TIPS Endoprosthesis with Unistep Plus Delivery System
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·NEW JERSEY LCS TOTAL KNEE SYSTEM
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·EZ Steer Non- Navigational 8mm (DS) ; EZ Steer DS ; EZ Steer Non-Navigational 4mm (TC) & (THR) ; Celsius 4mm Bi-Dir T ;
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·EZ Steer Smart Touch; Thermocooll ST Uni
Filler, Bone Void, Synthetic Peptide
FDA Pre-Market Approval
FDA Class 3
·i-FACTOR Peptide Enhanced Bone Graft
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
FDA Pre-Market Approval
FDA Class 3
·EZ Steer Navigational 4mm; C3 EZ Steer Thermocool Nav; Ez Steer Thermocool Non-Navigational 4mm (TC); EZ Steer Thermocoo