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

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SENSAR SOFT ACRYLIC UV LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·CRYOCOR CRYOABLATION SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RESTYLANE SILK SPHAL

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Restylane® Kysse

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Juvéderm Volux XC

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·JUVEDERM VOLLURE XC

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·INTELLANAV STABLEPOINT™ Ablation Catheter & Force Sensing System on the RHYTHMIA HDX™ Mapping System

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·Blazer Open-Irrigated Ablation Catheter and IntellaNav Open-Irrigated Ablation Catheter

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval
FDA Class 3 ·PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·ROTAPRO™ Rotational Atherectomy System

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·CraniSeal Dural Sealant

Implant, Dermal, For Aesthetic Use In The Hands

FDA Pre-Market Approval
FDA Class 3 ·Restylane Lyft with Lidocaine

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·JUVEDERM VOLBELLA XC

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval
FDA Class 3 ·COROMETRICS MODEL 146-FETAL ACOUSTIC STIMULATOR

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval
FDA Class 3 ·COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval
FDA Class 3 ·FETAL ACOUSTIC STIMULATOR (FAST)

Stimulator, Fetal, Acoustic

FDA Pre-Market Approval
FDA Class 3 ·COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR