BEUDAMED
    3,572 results · 41ms · Sources: EU EUDAMED, US FDA

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    FDA Pre-Market Approval
    FDA Class 2 ·SCHNEIDER MICROSOFTRAC PTCA CATHETER SCHNEIDER FREEFLIGHT 20/30/40 PTCA CATHETER

    Anti-Human Globulin, Fta-Abs Test

    FDA classification
    FDA Class 2 ·Anti-Human Globulin, Fta-Abs Test

    Bliss Concept DM SRL

    Importer
    🇷🇴 Romania

    Immunohistochemistry Assay, Antibody, Ki-67

    FDA Pre-Market Approval
    FDA Class 3 ·Ki-67 IHC MIB-1 pharmDx (Dako Omnis)

    Filler, Bone Void, Non-Osteoinduction

    FDA Pre-Market Approval
    FDA Class 3 ·NEUGRAFT

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    FDA Pre-Market Approval
    FDA Class 3 ·STRATOS LV/LV-T CRT-P; COROX OTW (-S) BP & PTW-L BP LEADS

    Active Era First Aid Kit 180 pcs – Refill

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·1 device

    Active Era First Aid Kit 320 pcs – Red

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·1 device

    Active Era First Aid Kit 180 pcs – Red

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·1 device

    Active Era First Aid Kit 120 pcs – Red

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·1 device

    Cancer Antigen 125(CLIA)、CA125 Calibrators

    Basic UDI-DI
    EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

    VID83-

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·VivaChek Biotech (Hangzhou) Co., Ltd.·1 device

    Antisera, Fluorescent Antibody For Fta-Abs Test

    FDA classification
    FDA Class 2 ·Antisera, Fluorescent Antibody For Fta-Abs Test

    Antigen, Treponema Pallidum For Fta-Abs Test

    FDA classification
    FDA Class 2 ·Antigen, Treponema Pallidum For Fta-Abs Test

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·SVS APEX (FORMERLY OMNIMED) EXCIMER LASER SYSTEM FOR PHOTOREFRACTIVE KERATECTOMY (PRK)

    Cook Medical Europe Ltd

    Importer
    🇮🇪 Ireland·9 Manufacturers

    Hu-Fa Dental a.s.

    Importer
    🇨🇿 Czechia

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·DIASORIN HBSAG CONFIRMATORY TEST

    Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

    FDA Pre-Market Approval
    FDA Class 3 ·TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System

    Filler, Bone Void, Synthetic Peptide

    FDA Pre-Market Approval
    FDA Class 3 ·PearlMatrix™ Bone Graft