82 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Prosthesis, Ankle, Uncemented, Non-Constrained
FDA Pre-Market Approval
FDA Class 3
·STAR PSI System
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT/ANTI-HBS CALIBRATORS
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella 2.5 System, Impella CP System and Impella CP System with SmartAssist System, Impella 5.0 System, Impella LD Syst
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella 2.5, Impella CP, Impella CP with SmartAssist
Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees
FDA Pre-Market Approval
FDA Class 3
·OPRA Implant System
Hepatitis Delta Serological Reagents
FDA Pre-Market Approval
FDA Class 3
·ABBOTT ANTI-DELTA DIAGNOSTIC KIT (RIA)
Hepatitis Delta Serological Reagents
FDA Pre-Market Approval
FDA Class 3
·ABBOTT ANTI-DELTA EIA
Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees
FDA Pre-Market Approval
FDA Class 3
·OPRA Implant System
Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees
FDA Pre-Market Approval
FDA Class 3
·OPRA Implant System
Hepatitis Delta Serological Reagents
FDA Pre-Market Approval
FDA Class 3
·ABBOTT ANTI-DELTA DIAGNOSTIC KIT (RIA)
Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees
FDA Pre-Market Approval
FDA Class 3
·OPRA Implant System
Implant, Dermal, For Aesthetic Use In The Hands
FDA Pre-Market Approval
FDA Class 3
·Restylane Lyft with Lidocaine
Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees
FDA Pre-Market Approval
FDA Class 3
·OPRA System
Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees
FDA Pre-Market Approval
FDA Class 3
·OPRA System
Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees
FDA Pre-Market Approval
FDA Class 3
·OPRA Implant System
Hepatitis Delta Serological Reagents
FDA Pre-Market Approval
FDA Class 3
·ABBOTT ANTI-DELTA (EIA) ASSAY
Implant, Dermal, For Aesthetic Use In The Hands
FDA Pre-Market Approval
FDA Class 3
·RADIESSE INJECTABLE IMPLANT
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·IMPELLA 2.5 System
Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter
FDA Pre-Market Approval
FDA Class 3
·AGENT Paclitaxel-Coated Balloon Catheter
Intravascular Radiation Delivery System
FDA Pre-Market Approval
FDA Class 3
·BETA-CATH (TM) SYSTEM