10,000 results · 39ms · Sources: EU EUDAMED, US FDA

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·Pipeline Flex Embolization Device

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·PIPELINE EMBOLIZATION DEVICE

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·PIPELINE EMBOLIZATION DEVICE

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·Pipeline™ Flex Embolization Device with Shield Technology™ (PED2), Pipeline™ Vantage Embolization Device with Shield Tec

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·Pipeline Flex Embolization Device

Non sterile: Adult Diaper

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Samela, Inc. d/b/a NorthShore Care Supply·1 device

Immunohistochemistry Assay, Antibody, Met

FDA Pre-Market Approval
FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

Immunohistochemistry Assay, Antibody, Claudin 18

FDA Pre-Market Approval
FDA Class 3 ·VENTANA CLDN18 (43-14A) RxDx Assay

Immunohistochemistry Assay, Antibody, Folr1

FDA Pre-Market Approval
FDA Class 3 ·VENTANA FOLR1 (FOLR-2.1) RxDx Assay

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

DISTRIBUCIONES DE OPTICA MGB SA

Authorized representative
🇪🇸 Spain·1 Manufacturer

GB19/964802

Certificate
MDD Annex V·Clinisupplies GB Limited·SGS Belgium NV·2 Basic UDI-DIs

RGB di Stefano Gabrielli e c SAS

Importer
🇮🇹 Italy

Comfort Turn

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Sizewise Rentals LLC Raye's, Inc. D/B/A Sizewise Manufacturing·2 devices

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·VENTANA PD-L1 (SP142) Assay

DGS Diagnostics A/S

System producer
🇩🇰 Denmark

RGB MEDICAL DEVICES, S.A.

System producer
🇪🇸 Spain

HL60145538

Certificate
IVDD Annex IV (excluding sections 4, 6)·GB Lifecare Co., Ltd.·TÜV Rheinland LGA Products GmbH·2 Basic UDI-DIs

db-die Beraterapotheke B.V.

Importer
🇳🇱 Netherlands·1 Manufacturer

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval
FDA Class 3 ·VENTANA MEDICAL SYSTEMS PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY