521 results
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42ms
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Sources: EU EUDAMED, US FDA
Filters
FDA Pre Market Approval
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Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC MODEL 7221 B/C/CX/D/E MICRO JEWEL W/MODEL 5434 ACTIVE CAN EMULATOR AND MODEL 9894
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·ACX RX COMET VP CORONARY DILATATION CATHETER
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·HARTZLER ACX II(R) CORONARY DILATATION CATHETER
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·ACS HARTZLER ACX II CORONARY DILATATION BALLOON CA
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·GEM VR MODELS 7227 B/D/E/CX
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·MODEL 7220 B/C/D/E JEWEL(R) PLUS, 7202 D/E, 7219 BDE, 7221 B/C/CXDE
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK
Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection
FDA Pre-Market Approval
FDA Class 3
·GENESEARCH BREAST LYMPH NODE ASSAY
Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection
FDA Pre-Market Approval
FDA Class 3
·GENESEARCH BREAST LYMPH NODE
Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection
FDA Pre-Market Approval
FDA Class 3
·GENESEARCH BREAST LYMPH NODE (BLN) ASSAY
Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection
FDA Pre-Market Approval
FDA Class 3
·GENESEARCH BREAST LYMPH NODE(BLN) ASSAY
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP System
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP and Impella RP with SmartAssist
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·ROTABLATOR(R)
Absorbable Collagen Hemostatic Agent With Thrombin
FDA Pre-Market Approval
FDA Class 3
·HEMOBLAST Bellows
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·SIMPSON CORONARY ATHEROCATH(TM)
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM
Absorbable Collagen Hemostatic Agent With Thrombin
FDA Pre-Market Approval
FDA Class 3
·Floseal Hemostatic Matrix
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·Rotablatorand ROTAPRO Rotational Atherectomy System
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·SIMPSON CORONARY ATHEROCATH(R) SCA-I(TM),SCA-LP(TM