115 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Lenses, Soft Contact, Extended Wear
FDA Pre-Market Approval
FDA Class 3
·FRESHLOOK(TM) UV SPHERICAL (PHEMFILCON A) MOLDED SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·ICS 3000 IMPLANT CONTROL SYSTEM
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·Implantable System for Remodulin
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·PHYLAX AV ICD SYSTEM
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·KRONOS LV-T CRT-D
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·PHYLAX IMPLANTABLE CARDIOVERTER DIFIBRILLATOR
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC
Nitric Oxide Generator And Delivery System
FDA Pre-Market Approval
FDA Class 3
·LungFit PH
Nitric Oxide Generator And Delivery System
FDA Pre-Market Approval
FDA Class 3
·LungFit PH
Nitric Oxide Generator And Delivery System
FDA Pre-Market Approval
FDA Class 3
·LungFit PH
Nitric Oxide Generator And Delivery System
FDA Pre-Market Approval
FDA Class 3
·LungFit PH
Nitric Oxide Generator And Delivery System
FDA Pre-Market Approval
FDA Class 3
·LungFit PH
Nitric Oxide Generator And Delivery System
FDA Pre-Market Approval
FDA Class 3
·LungFit PH
Nitric Oxide Generator And Delivery System
FDA Pre-Market Approval
FDA Class 3
·LungFit PH
Nitric Oxide Generator And Delivery System
FDA Pre-Market Approval
FDA Class 3
·LungFit PH
Nitric Oxide Generator And Delivery System
FDA Pre-Market Approval
FDA Class 3
·LungFit PH
Permanent Pacemaker Electrode
FDA Pre-Market Approval
FDA Class 3
·PHILOS PULSE GENERATORS AND ASSOCIATED PROGRAMMER SOFTWARE.
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·ISERT PY-60AD
Nitric Oxide Generator And Delivery System
FDA Pre-Market Approval
FDA Class 3
·LungFit® PH
Temporary Non-Roller Type Right Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella RP System