BEUDAMED
    3,286 results · 41ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    Immunohistochemistry Assay, Antibody, Ki-67

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

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·PD-L1 IHC 28-8 PHARMDX (MELANOMA INDICATION)

    NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER

    FDA UDI
    NIPRO MEDICAL CORPORATION·00383790001274·DULL FISTULA NEEDLE for Established Access Site...

    Centricity Radiology RA600 v8.0; Centricity Cardiology CA1000 v2.0; Centricity Digital Hardcopy (DHC) v2.0

    Device
    EU MDD · Eu Md Class 2a ·GE Healthcare·On the market·22 countries

    Centricity Radiology RA600 v7.0; Centricity Cardiology CA1000 v1.0; Centricity Digital Hardcopy (DHC) v1.0

    Device
    EU MDD · Eu Md Class 2a ·GE Healthcare·On the market·22 countries

    FAC-3 - Class B 21 Kent - 3 Shelf Cabinet

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588620855·FAC-3 - Class B 21 Kent - 3 Shelf Cabinet

    FAC-3 - Class B 21 Lawson - 3 Shelf Cabinet

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588620848·FAC-3 - Class B 21 Lawson - 3 Shelf Cabinet

    FAC-4 - Class B 21 Lawson - 4 Shelf Cabinet

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588620862·FAC-4 - Class B 21 Lawson - 4 Shelf Cabinet

    FAC-4 - Class B 21 Kent - 4 Shelf Cabinet

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588620879·FAC-4 - Class B 21 Kent - 4 Shelf Cabinet

    FAC-5 - Class B 21 Lawson - 5 Shelf Cabinet

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588620886·FAC-5 - Class B 21 Lawson - 5 Shelf Cabinet

    FAC-5 - Class B 21 Kent - 5 Shelf Cabinet

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588620893·FAC-5 - Class B 21 Kent - 5 Shelf Cabinet

    HUMAN (IGG) SUBCLASS (EIA) KIT

    FDA 510(k)
    FDA Class 1 ·Immunology

    AMINOGLYCOSIDE CONTROLS

    FDA 510(k)
    FDA Class 1 ·Immunology

    HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT

    FDA 510(k)
    FDA Class 1 ·Immunology

    ANTISERUM TO HUMAN IG G FC FRAGMENTS

    FDA 510(k)
    FDA Class 1 ·Immunology

    HUMAN IGG SUBCLASSES ELISA COMBI KIT

    FDA 510(k)
    FDA Class 1 ·Immunology

    HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION)

    FDA 510(k)
    FDA Class 1 ·Immunology

    PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT

    FDA 510(k)
    FDA Class 1 ·Immunology

    ANTISERUM TO HUMAN FC

    FDA 510(k)
    FDA Class 1 ·Immunology

    Crit-Line®

    FDA UDI
    Fresenius Usa, Inc.·00840861102020·Blood Chamber II