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

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Paragon CRT®, Paragon CRT®100, Paragon CRT Dual Axis®, Paragon RG-4™ Rigid Gas Permeable Contact Lenses in Clear and Tin

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval
FDA Class 3 ·Paragon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval
FDA Class 3 ·Paragon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints

Implant, Intragastric For Morbid Obesity

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

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Paragon CRT (paflufocon B), Paragon CRT 100 (paflufocon D), Paragon CRT Dual Axis (paflufocon D) and Paragon RG-4 (paflu

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval
FDA Class 3 ·Paragon Z CRT (tisilfocon A) and Paragon Z CRT Dual Axis (tisilfocon A) Rigid Gas Permeable Contact lenses in blue tint

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Paragon CRT, Paragon CRT 100, Paragon CRT Dual Axis, and Paragon RG-4 Rigid Gas Permeable Contact Lenses in Clear and Ti

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Paragon CRT, Paragon CRT 100, Paragon CRT Dual Axis and Paragon RG-4 Rigid Gas Permeable Contact Lenses in Clear and Tin

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Paragon CRT Paragon CRT 100, Paragon CRT Dual Axis and Paragon RG-4 Rigid Rigid Gas Permeable Contact Lenses in Clear an

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·RESHAPE INTEGRATED DUAL BALLOON SYSTEM

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·OBALON BALLOON SYSTEM

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·Obalon Balloon Kit

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·iDESIGNRefractive Studio, STAR Excimer Laser System

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·ORBERA INTRAGASTRIC BALLOON

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·ORBERA Intragastric Balloon

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·SYNCHRONY MODELS PARAGON III/PHOENIX III PACERS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·ENPULSE INPLANTABLE PULSE GENERATOR

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·SYNERGYST II PULSE GENERATOR