262 results · 20ms · Sources: EU EUDAMED, US FDA

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ST. JUDE MEDICAL MECHANICAL HEART VALVE

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SynchroMed® Infusion System, Ascenda® Intrathecal Catheters

THREADED PINS

FDA 510(k)
FDA Class 3 ·Unknown

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Sensar 1-Piece IOL, Tecnis 1-Piece IOL, OptiBlue 1-Piece IOL, iTec Preloaded Delivery System, Multifocal 1-Piece IOL, Mu

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·LIFEPAK® 1000 Defibrillator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartSine’s Samaritan® Public Access Automated External Defibrillators

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·LIFEPAK® 35 Monitor/Defibrillator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·X Series, Propaq MD

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·CPR-D-padz One-Piece Electrode Pad with Real CPR Help, OneStep CPR Complete Electrode, Pro-padz Biphasic Electrode, Pro-

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartStart FRx Defibrillator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartSine's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)

Ring, Endocapsular

FDA Pre-Market Approval
FDA Class 3 ·MORCHER® EYEJET® CTR Single-Use Injector

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·LIFEPAK CR2 Automated External Defibrillator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·LIFEPAK Automated External Defibrillator (AED)

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartStart FRx Defibrillator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·LIFEPAK® CR2 Defibrillator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·CPR-D-padz electrode

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·HeartStart FR3 Defibrillator