BEUDAMED
    14 results · 25ms · Sources: EU EUDAMED, US FDA

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    AMS OPTILUME INFLATION SYRINGE

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

    Keystone Industries

    FDA UDI
    Keystone Industries·H66819007601·Pkg/10x1 Ft Clasp Wire 17Ga Rd

    BONE MULCH TRAY

    FDA UDI
    Biomet Orthopedics, LLC·00880304479944·

    3D

    FDA UDI
    Rmo, Inc.·00885797100153·3D LING ARCH ASST 30

    CooperSurgical, Inc.

    FDA UDI
    Coopersurgical, Inc.·00888937003680·1X Macro Bipolar Insert

    THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120

    FDA 510(k)
    FDA Class 2 ·Immunology

    REACH FEMORAL COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SODIUM CHLORIDE INHALATION SOLUTION 3%

    FDA Adverse Event
    NEPHRON SC, INC.·Product code CAF·December 3, 2021

    EVOLUT R TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·September 1, 2021

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 27, 2014

    UNICEL® DXI 600 ACCESS® IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·November 16, 2010

    DA VINCI S

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL·Product code NAY·January 3, 2013

    Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-9007-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For respiratory therapy, Solium Chloride Inhalation Solution USP, 3% is used in conjunction with a nebulizer

    FDA Enforcement
    Class II ·Terminated·Nephron Pharmaceuticals Corp.·July 6, 2016

    Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-9007-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For respiratory therapy, Solium Chloride Inhalation Solution USP, 3% is used in conjunction with a nebulizer

    FDA Recall
    Terminated ·Nephron Pharmaceuticals Corp.·Product code CAF·November 16, 2015