414 results · 19ms · Sources: EU EUDAMED, US FDA

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Reveal LINQ Application Software

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·CareLink Programmer (Model 2090), Encore Programmer (Model 29901)

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval
FDA Class 3 ·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval
FDA Class 3 ·REVEAL LINQ SOFTWARE MODEL SWO26

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Restylane Injectable Gels

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, DR MRI IPG, ENPULSE EL IPG, E2 IPG, ENRHYTHM IPG, KAPPA D IPG

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

FDA Pre-Market Approval
FDA Class 3 ·CONSULTA CRT-P, SYNCRA CRT-P

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·INSYNC II PROTECT ICD, IIIMARQUIS ICD, MARQUIS ICD, MAXIMO ICD, BRAVA CRT-D, CONCERTO ICD, II CRT-D, CONSULTA ICD, MAXIM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ENTRUST ICD, INTRINSIC 30ICD, MARQUIS DR ICD, VR ICD, MAXIMO DR ICD, VR ICD, EVERA S DR ICD, S VR ICD,XT VR ICD, MAXIMO

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·MYCARELINK PATIENT MONITOR, DEVICE DATA MANAGEMENT APPLICATION, APPLICATION SOFTWARE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·REVO MRI IPG

Applicator, Hyperthermia, Superficial, Rf/Microwave

FDA Pre-Market Approval
FDA Class 3 ·HYPERTHERMIA SYSTEM 100 A

Applicator, Hyperthermia, Deep Heating, Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM

Cap, Cervical, Contraceptive

FDA Pre-Market Approval
FDA Class 3 ·PRENTIF TM CAVITY RIM CERVICAL CAP

Applicator, Hyperthermia, Superficial, Rf/Microwave

FDA Pre-Market Approval
FDA Class 3 ·HYPERTHERMIA SYSTEM 100 A

Cap, Cervical, Contraceptive

FDA Pre-Market Approval
FDA Class 3 ·LEA'S SHIELD BARRIER CONTRACEPTIVE

Cap, Cervical, Contraceptive

FDA Pre-Market Approval
FDA Class 3 ·FEMCAP BARRIER CONTRACEPTIVE

Cap, Cervical, Contraceptive

FDA Pre-Market Approval
FDA Class 3 ·FEMCAP CONTRACEPTIVE BARRIER DEVICE

Applicator, Hyperthermia, Deep Heating, Ultrasound

FDA Pre-Market Approval
FDA Class 3 ·SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM

Cap, Cervical, Contraceptive

FDA Pre-Market Approval
FDA Class 3 ·LEA'S SHIELD BARRIER CONTRACEPTIVE