77 results · 18ms · Sources: EU EUDAMED, US FDA

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