2,762 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Stent, Urethral, Prostatic, Semi-Permanent
FDA Pre-Market Approval
FDA Class 3
·THE SPANNER TEMPORARY PROSTATIC STENT
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
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT PRODUCT
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·X Series, Propaq MD
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR AHBS
Ophthalmic Sealant
FDA Pre-Market Approval
FDA Class 3
·RESURE SEALANT
Biologic Material, Dental
FDA Pre-Market Approval
FDA Class 3
·EMDOGAIN GEL
Antigen(Complexed),Prostate Specific,(Cpsa)
FDA Pre-Market Approval
FDA Class 3
·Adiva Centaur Complexed PSA (cPSA) Immunoassay and Atellica IM cPSA Immunoassay
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·CPR-D-padz One-Piece Electrode Pad with Real CPR Help, OneStep CPR Complete Electrode, Pro-padz Biphasic Electrode, Pro-
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·Axonics Sacral Neuromodulation System
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·Orthovisc, Sodium Hyaluronic
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN
Acid, Hyaluronic, Intraarticular
FDA Pre-Market Approval
FDA Class 3
·SYNVISC-ONE
System, Hemodynamic, Implantable
FDA Pre-Market Approval
FDA Class 3
·CardioMEMS HF System
Device, Incontinence, Mechanical/Hydraulic
FDA Pre-Market Approval
FDA Class 3
·AMS 800 Artificial Urinary Sphincter
System, Identification, Contact Lens
FDA Pre-Market Approval
FDA Class 3
·SOFTMARK
System, Hemodynamic, Implantable
FDA Pre-Market Approval
FDA Class 3
·CARDIOMEMS HF SYSTEM
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella 2.5, CP, and CP with SmartAssist
Agent, Bulking, Injectable For Gastro-Urology Use
FDA Pre-Market Approval
FDA Class 3
·BARD TEGRESS URETHRAL IMPLANT
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·ABIOMED BVS(R) 5000 BI-VENTRICULAR SUPPORT SYSTEM