3,705 results · 43ms · Sources: EU EUDAMED, US FDA

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Tendril MRI

Implantable Pacemaker Pulse-Generator

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

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·ST.JUDE MEDICAL ICDS/CRT-D

Electrosurgical, Radio Frequency, Refractive Correction

FDA Pre-Market Approval
FDA Class 3 ·VIEWPOINT CK SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·NIDEK EXCLAIMER LASER SYSTEM EC-5000

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)EXTENDED WEAR CONTACT LENS

Ferritin, Antigen, Antiserum, Control

FDA classification
FDA Class 2 ·Ferritin, Antigen, Antiserum, Control

Gamma Globulin, Fitc, Antigen, Antiserum, Control

FDA classification
FDA Class 2 ·Gamma Globulin, Fitc, Antigen, Antiserum, Control

QUANTA Lite® F-Actin IgA ELISA

FDA UDI
INOVA DIAGNOSTICS, INC.·08426950594093·1. 1x F-Actin ELISA microwell plate (12-1 x 8 w...

Determine HIV Early Detect

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Abbott Diagnostics Medical Co., Ltd.·1 device

EDTA Capillary Tubes

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Abbott Diagnostics Medical Co., Ltd.·1 device

Determine HIV Controls

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Abbott Diagnostics Medical Co., Ltd.·1 device

Chase Buffer

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Abbott Diagnostics Medical Co., Ltd.·1 device

Synthon auto-injector (brand names:MyJect, Autoxon, Perscleran, Sensigo)

Basic UDI-DI
EU MDR · Eu Md Class 2a ·Synthon Hispania S.L.·2 devices

Abbott Rapid Dx International Limited

Importer
🇮🇪 Ireland·11 Manufacturers

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·IC-8 Apthera Intraocular Lens (IOL)

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·LASERVISION/VISX EXCIMER LASER MODEL C

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·AcrySof™ IQ Vivity™ Extended Vision, Toric Extended Vision, Extended Vision UV Absorbing, and Toric Extended Vision UV A

ITENA CLINICAL

Importer
🇫🇷 France·10 Manufacturers

Abbott Rapid Dx International Limited

Authorized representative
🇮🇪 Ireland·5 Manufacturers·4 Devices