6,175 results · 43ms · Sources: EU EUDAMED, US FDA

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS TORIC 1-PIECE INTRAOCULAR LENSES (IOLS) EXTENDED CYLINDER RANGE (ECR), MODELS ZCT450, ZCT525 AND ZCT600

Pas za stomo

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Alisa trgovina in storitve Alenka Stopar s.p.·2 devices

Pas za stomo

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Alisa trgovina in storitve Alenka Stopar s.p.·2 devices

pas za stomo

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Alisa trgovina in storitve Alenka Stopar s.p.·2 devices

Pas uniwersalny brzuszny

Basic UDI-DI
EU MDR · Eu Md Class 1 ·mdh sp. z o. o.·1 device

Pas stomijny brzuszny

Basic UDI-DI
EU MDR · Eu Md Class 1 ·mdh sp. z o. o.·1 device

Pas krzyżowy ocieplany

Basic UDI-DI
EU MDR · Eu Md Class 1 ·mdh sp. z o. o.·1 device

PAS Stain Kit

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·VITRO, S.A.·1 device

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP, Impella RP with SmartAssist

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·Prolieve Thermodilation System

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·ENROUTE Transcarotid Stent System

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

FDA Pre-Market Approval
FDA Class 3 ·XVIVO Perfusion System (XPS) with STEEN Solution

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·LUTONIX 035 Drug Coated Balloon PTA Catheter, Model 9010

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EMBLEM S-ICD VI Electrode (Lead)

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval
FDA Class 3 ·SUPERION INTERSPINOUS SPACER

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·Raindrop® Near Vision Inlay

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval
FDA Class 3 ·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear

Ophthalmic Sealant

FDA Pre-Market Approval
FDA Class 3 ·ReSure Sealant

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Assurity MRI, Endurity MRI family of Pacemakers