BEUDAMED
    57 results · 26ms · Sources: EU EUDAMED, US FDA

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    MODEL #527 OPHTHALMIC STRETCHER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TRU UCLA Abutment RP Engaging - Plastic

    FDA UDI
    STERNGOLD DENTAL LLC·00841549110191·TRU UCLA Abutment RP Engaging - Plastic. The U...

    SUTURE RETRIEVER

    FDA UDI
    Biomet Orthopedics, LLC·00880304563704·

    FACTOR XI DEFICIENT PLASMA

    FDA 510(k)
    FDA Class 2 ·Hematology

    IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IV SET AN120 W/O BP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·May 9, 2019

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 9, 2015

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 9, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 1, 2014

    IV SET AN125 W/O BP 200C

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·August 14, 2019

    Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

    FDA Enforcement
    Class I ·Ongoing·Zyno Medical LLC·June 18, 2025

    N-terminal pro-B-type Natriuretic Peptide &Cardiac Troponin I Combo Test Kit (Fluorescence Immunochromatographic Assay)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device

    Beta 2 microglobulin (β2-MG) Test Kit (Fluorescence Immunochromatographic Assay)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device

    Serum Amyloid A (SAA) & Full C-reactive protein (CRP) Combo Test Kit (Fluorescence Immunochromatographic Assay)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device

    Procalcitonin (PCT) & Full C-reactive protein (CRP) Combo Test Kit (Fluorescence Immunochromatographic Assay)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device

    Thyroid Stimulating Hormone(TSH) Test Kit (Fluorescence Immunochromatographic Assay)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device

    Total Thyroxine(T4) Test Kit (Fluorescence Immunochromatographic Assay)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device

    Total Triiodothyronine(T3) Test Kit (Fluorescence Immunochromatographic Assay)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device

    Myoglobin (Myo) Test Kit (Fluorescence Immunochromatographic Assay)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device

    Cardiac Troponin I (cTnI) Test Kit (Fluorescence Immunochromatographic Assay)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device