10,000 results · 50ms · Sources: EU EUDAMED, US FDA

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·STORZ POSTERIOR CHAMBER INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODELS PC10 & PC21

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·AFP CARDIAC PACING SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·UV/ABSORBING POSTERIOR CHAMBER IOL

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·MynxGrip Vascular Closure Device

Implant, Auditory Brainstem

FDA Pre-Market Approval
FDA Class 3 ·Nucleus 24 Auditory Brainstem Implant System

Implant, Auditory Brainstem

FDA Pre-Market Approval
FDA Class 3 ·Nucleus® 24 Auditory Brainstem Implant System

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·Alinity i Anti-HBc Reagent Kit (2x100 Tests), Alinity i Anti-HBc Reagent Kit (2x600 Tests)

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

FDA Pre-Market Approval
FDA Class 3 ·SAFIRE BLU DUO ABLATION CATHETERS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM ASSAY

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·TRANSVENE SVC LEAD

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·AMS 800 URINARY CONTROL SYSTEM (AUS)

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·GYNECARE THERMACHOICE UTERINE BALLON THERAPY SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADVISA DR IPG

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval
FDA Class 3 ·IMPLANTABLE BONE GROWTH STIMULATOR

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·OSTEONICS ABC/TRIDENT SYSTEMS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL PC-42ANB POSTERIOR IOL

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·REVO MRI, ENRHYTHM MRI

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·GENESIS NEUROSTIMULATION (IPG) SYSTEM