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

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    BODYFORM THORACIC FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PACEART TX3 CARDIAC EVENT RECORDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FAST1 INTRAOSSEOUS INFUSION SYSTEM

    FDA Adverse Event
    Other ·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009

    FAST1 INTRAOSSEOUS INFUSION SYSTEM

    FDA Adverse Event
    Other ·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009

    FAST1 INTRAOSSEOUS INFUSION SYSTEM

    FDA Adverse Event
    Other ·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009

    FAST1 INTRAOSSEOUS INFUSION SYSTEM

    FDA Adverse Event
    Other ·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·April 23, 2013

    CUSTOM PAK

    FDA Adverse Event
    Malfunction ·ALCON - HOUSTON·Product code KYG·April 8, 2011

    ATTAIN OTW

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWP·July 10, 2008

    ARCHITECT ANTI-TPO

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·September 11, 2025

    ALINITY I ANTI-TPO REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·December 10, 2025

    ALINITY I ANTI-TPO REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·December 10, 2025

    BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·December 28, 2020

    ALINITY I ANTI-TPO REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·September 16, 2025

    ARCHITECT ANTI-TPO REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JZO·May 23, 2025

    ALINITY I ANTI-TPO REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·March 17, 2025

    KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

    FDA 510(k)
    FDA Class 2 ·Neurology

    CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012