10,000 results · 48ms · Sources: EU EUDAMED, US FDA

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·TRIDYNE VASCULAR SEALANT

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·MEDTONIC FREESTYLE AORTIC BIOPROSTHESIS

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·CentriMag Circulatory Support System

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·HiResolution Bionic Ear System

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Saluda Medical Evoke SCS System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SYNCHROMED INFUSION SYSTEM

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP System

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval
FDA Class 3 ·PORTACATH/II EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·PASSIVE PLUS DX STEROID ELUTING, ENDOCARDIAL PACING LEADS

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·CLEAR SOFT (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·METHAFILCON A

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·FLOSEAL NT HEMOSTATIC MATRIX

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·APLIGRAF (GRAFTSKIN)

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·LADARVISION 4000 EXCIMER LASER SYSTEM

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·HBV ASSAY

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·IMPELLA LEFT VENTRICULAR SUPPORT SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·LADARVISION 4000 EXCIMER LASER SYSTEM