10,000 results · 36ms · Sources: EU EUDAMED, US FDA

Welch Allyn, Inc.

FDA UDI
WELCH ALLYN, INC.·00732094259193·XScribe Cardiac Stress - version 6 with adult a...

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Pulse Generator, Permanent Implantable

Immunohistochemistry Antibody Assay, C-Kit

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

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

Gastric Lightguide (GLG)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Cassini

FDA registration
HITTECH MULTIN BV·1 product·🇳🇱 Netherlands

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·GAMMA DAB (125I) AFP RIA KIT

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Lutonix 035 DCB PTA Catheter Balloon

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·GAMMA DAB (125I) AFP RIA KIT

N-Histofine DAB-2V

Device
EU IVDR · Eu Ivd Class A ·Nichirei Biosciences Inc.·On the market·10 countries

N-Histofine DAB-2V

Device
EU IVDR · Eu Ivd Class A ·Nichirei Biosciences Inc.·On the market·10 countries

N-Histofine DAB-2V

Device
EU IVDR · Eu Ivd Class A ·Nichirei Biosciences Inc.·On the market·10 countries

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SPRINT QUATTRO SECURE LEADS MODELS 6935 & 6947

PATIENT EXAMINATION GLOVES (LATEX)

FDA 510(k)
FDA Class 1 ·General Hospital

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT™ Admiral™ Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Stellarex 035 OTW Drug-Coated Angiopiasty Balloon (DCB)

PolyQ Stain DAB, 2 components

Device
EU IVDR · Eu Ivd Class A ·biocyc Biotechnologie GmbH & Co. KG·On the market

PolyQ Stain DAB, 2 components

Device
EU IVDR · Eu Ivd Class A ·biocyc Biotechnologie GmbH & Co. KG·On the market

PolyQ Stain DAB, 2 components

Device
EU IVDR · Eu Ivd Class A ·biocyc Biotechnologie GmbH & Co. KG·On the market

PolyQ Stain DAB, 2 components

Device
EU IVDR · Eu Ivd Class A ·biocyc Biotechnologie GmbH & Co. KG·On the market