77 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Tympanostomy Tube Delivery Product With Drug
FDA Pre-Market Approval
FDA Class 3
·Tula® System
Tympanostomy Tube Delivery Product With Drug
FDA Pre-Market Approval
FDA Class 3
·Tula® System
Tympanostomy Tube Delivery Product With Drug
FDA Pre-Market Approval
FDA Class 3
·Tula System
Tympanostomy Tube Delivery Product With Drug
FDA Pre-Market Approval
FDA Class 3
·Tula® System
Tympanostomy Tube Delivery Product With Drug
FDA Pre-Market Approval
FDA Class 3
·Tula® System
Tympanostomy Tube Delivery Product With Drug
FDA Pre-Market Approval
FDA Class 3
·Tula System
Tympanostomy Tube Delivery Product With Drug
FDA Pre-Market Approval
FDA Class 3
·Tula® System
Tympanostomy Tube Delivery Product With Drug
FDA Pre-Market Approval
FDA Class 3
·Tula System
Tympanostomy Tube Delivery Product With Drug
FDA Pre-Market Approval
FDA Class 3
·Tula SystemTube Delivery System (TDS)
Tympanostomy Tube Delivery Product With Drug
FDA classification
FDA Class 3
·Tympanostomy Tube Delivery Product With Drug
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·OCUFILCON D SOFT (HYDROPHILIC) CONTACT LENSES
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK AND CALIBRATOR
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·MARQUIS, MAXIMO, INSYNC, ENTRUST, AND INTRINSIC FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·MARQUIS, MAXIMO, INSYNC, ENTRUST, AND INTRINSIC FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)
Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·Organ Care System (OCS) Lung System
Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·Organ Care System (OCS) Lung
Intracranial Coil-Assist Stent
FDA Pre-Market Approval
FDA Class 3
·Neuroform Atlas® Stent System
Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·Organ Care System (OCS) Lung System