328 results · 21ms · Sources: EU EUDAMED, US FDA

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Juvederm Ultra, Juvederm Ultra XC, Juvederm Ultra Plus, Juvederm Ultra XC, Juvederm 30 (Juvederm Forma)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY SYSTEM

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·COAPTITE INJECTABLE IMPLANT

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NEUROPACE RNS SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·VERIFLEX (LIBERTE) CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·EXPRESS 2 MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEM

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC VENTRICULAR ASSIST DEVICE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CapSure Fix MRI Lead

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CapSure Fix Novus Lead; Vitatron Crystalline Active Fixation Lead

Lenses, Soft Contact, Extended Wear

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

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval
FDA Class 3 ·HEMOBLAST™ Bellows

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval
FDA Class 3 ·QUANTIFERON - TB GOLD AND TB GOLD IN-TUBE

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ST JUDE MEDICAL PACEMAKERS

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·FRONTIER & FRONTIER II PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADAPTA/VERSA/SENSIA/RELIA IPGS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VR ICDS