241 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Catheter, Balloon, Transcervical
FDA Pre-Market Approval
FDA Class 3
·GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
Lymph Node Location System During Sentinel Biopsy Procedure
FDA Pre-Market Approval
FDA Class 3
·Magtrace and Sentimag Magnetic Locatization System (PUV)
Lymph Node Location System During Sentinel Biopsy Procedure
FDA Pre-Market Approval
FDA Class 3
·Magtrace® and Sentimag® Magnetic Locatization System (PUV)
Lymph Node Location System During Sentinel Biopsy Procedure
FDA Pre-Market Approval
FDA Class 3
·Magtrace® and Sentimag® Magnetic Locatization System (PUV)
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·ISERT PY-60AD
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·Organ Care System (OCS) Liver
Drug-Eluting Sinus Stent
FDA Pre-Market Approval
FDA Class 3
·PROPEL SINUS IMPLANT AND PROPEL MINI SINUS IMPLANT
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
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP, Impella RP with SmartAssist and RP Flex with SmartAssist
Lymph Node Location System During Sentinel Biopsy Procedure
FDA Pre-Market Approval
FDA Class 3
·Magtrace/and Sentimag Magnetic Localization System
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·Fluency® Plus Endovascular Stent Graft
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·FLAIR ENDOVASCULAR STENT GRAFT
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·BARD FLAIR ENDOVASCULAR STENT GRAFT
Lymph Node Location System During Sentinel Biopsy Procedure
FDA Pre-Market Approval
FDA Class 3
·Magtrace and Sentimag Magnetic Localization System
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP, Impella RP with SmartAssist
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·Fluency Endovascular Stent Graft
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
FDA Pre-Market Approval
FDA Class 3
·FLAIR ENDOVASCULAR STENT GRAFT