1,164 results · 26ms · Sources: EU EUDAMED, US FDA

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix DCB)

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix 018 DCB)

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix 018 DCB)

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT Admiral DCB Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·IPRO2 CGM SYSTEM WITH ENLITE SENSOR

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·MINIMED 630G SYSTEM WITH SMARTGUARD

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·Artificial Pancreas Device System, Threshold Suspend

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Sensor-Enabled Pump System-Continuous Glucose Monitoring System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·MyCareLink Patient Monitor, Device Command Library (DCL) , Device Data Management Application (DDMA) CareLink Express, C

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·SPINALOGIC 1000 BONE GROWTH STIMULATOR

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·ORTHOLOGIC 1000 SC

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·ORTHOLOGIC 1000 BONE GROWTH STIMULATOR/PATIENT REGISTRY MARKETING BROCHURE

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·SPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval
FDA Class 3 ·Scandinavian Total Ankle Replacement (S.T.A.R. Ankle)

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·SPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval
FDA Class 3 ·SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE)