11 results · 17ms · Sources: EU EUDAMED, US FDA

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval
FDA Class 3 ·JSZ ORTHOKERATOLOGY CONTACT LENSES FOR OVERNIGHT WEAR

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·AFFINITY SR MODELS 5130 (LS,RS,L,R)PULSE GENERATORS AFFINITY DR MODELS 5330 (LS, RS,L,R)PULSE GENERATORS

Automated External Defibrillators (Non-Wearable)

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

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval
FDA Class 3 ·JSZ ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·DUOVISC Ophthalmic Viscoelastic System (consists of PROVISC and VISCOAT), DISCOVISC Ophthalmic Viscosurgical Device

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·PROVISC Ophthalmic Viscosurgical Device

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·Ophthalmic Viscosurgical Devices

Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval
FDA Class 3 ·BAROSTIM NEO Implantable Pulse Generator (IPG), BAROSTIM NEO Carotid Sinus Lead (CSL) Kit, Programmer System, Carotid Si

Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval
FDA Class 3 ·BAROSTIM NEO Implantable Pulse Generator (IPG), BAROSTIM NEO Carotid Sinus Lead (CSL) Kit, Programmer System, Carotid Le

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·PARADYM RF CRT-D

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·PARADYM RF VR ICDS