BEUDAMED
    88 results · 24ms · Sources: EU EUDAMED, US FDA

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    Hepatitis A Test (Antibody And Igm Antibody)

    FDA Pre-Market Approval
    FDA Class 2 ·ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS

    GEN4 DIGITAL

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828108980·GEN4 DIGITAL

    GEN4 DIGITAL

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828110730·GEN4 DIGITAL

    GEN4 Direct Access

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828102605·GEN4 Direct Access

    25GA Curved Illuminating Probe, SMA906

    FDA UDI
    Peregrine Surgical, Llc·00632307001826·25GA Curved Illuminating Probe, SMA906

    GEN4 Direct Access

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828105477·GEN4 Direct Access

    GEN4 DIGITAL

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828112819·GEN4 DIGITAL

    GEN4 DIGITAL

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828109574·GEN4 DIGITAL

    GEN4 DIGITAL

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828109871·GEN4 DIGITAL

    GEN4 Direct Access

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828102650·GEN4 Direct Access

    GEN4 DIGITAL

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828109796·GEN4 DIGITAL

    GEN4 DIGITAL

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828132770·GEN4 DIGITAL

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710300400180·Tibial Osteotmy Guide, 40mm x 18mm

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710310400180·Talar Osteotmy Guide, 40mm x 18mm

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710820400180·Zadik Calcaneal Guide, 40mm x 18°

    EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Intravascular Radiation Delivery System

    FDA Pre-Market Approval
    FDA Class 3 ·BETA-CATH (TM) SYSTEM

    Electrosurgical, Radio Frequency, Refractive Correction

    FDA Pre-Market Approval
    FDA Class 3 ·VIEWPOINT(TM) CK SYSTEM

    Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168 4.0 Fr - SIPSF-040018-59 G32773 4.7 Fr SIPSF-050018-59 G32774

    FDA Recall
    Terminated ·Cook Inc.·Product code KOB·April 22, 2019

    Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168 4.0 Fr - SIPSF-040018-59 G32773 4.7 Fr SIPSF-050018-59 G32774

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·May 29, 2019