168 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
FDA Pre-Market Approval
FDA Class 3
·T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM
Drug-Coated Peripheral Transluminal Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
Drug-Coated Peripheral Transluminal Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·Lutonix 018
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP Flex with SmartAssist and Impella RP with SmartAssist
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
FDA Pre-Market Approval
FDA Class 3
·ANIMAS VIBE SYSTEM
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP System
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
FDA Pre-Market Approval
FDA Class 3
·t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
FDA Pre-Market Approval
FDA Class 3
·ANIMAS VIBE SYSTEM
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP and Impella RP with SmartAssist
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
FDA Pre-Market Approval
FDA Class 3
·Animas Vibe System
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP System
Drug-Coated Peripheral Transluminal Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Drug-Coated Peripheral Transluminal Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·Lutonix Drug Coated Balloon PTA Catheter
Drug-Coated Peripheral Transluminal Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·Lutonix Drug Coated Balloon
Drug-Coated Peripheral Transluminal Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
Drug-Coated Peripheral Transluminal Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·Lutonix Drug Coated Balloon PTA Catheter
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, Impella RP with SmartAssist