BEUDAMED
    12 results · 22ms · Sources: EU EUDAMED, US FDA

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    Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ULTRASONIC NEBULIZER SYSTEM, MODEL HL100

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 12, 2025

    BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·November 27, 2017

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·June 21, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code FZP·September 30, 2008

    30 G X 1/2 IN. BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE

    FDA Adverse Event
    Injury ·BD MEDICAL (BD EAST) PHARMACEUTICAL SYSTEMS·Product code FMI·March 16, 2016

    BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·January 13, 2016

    30 G X 1/2 IN. BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·November 6, 2017

    ALINITY C MAGNESIUM

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JGJ·February 16, 2026