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

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    Axiostat Patch

    FDA 510(k)
    FDA Unclassified ·Unknown

    Syntec Osteo-plate and screw Fixation

    FDA UDI
    SYNTEC SCIENTIFIC CORPORATION·04712782853946·Cortex Screw Self-Tappingφ2.7 x L30mm

    NA

    FDA UDI
    Synthes GmbH·10886982144812·2.7MM CORTEX SCREW SELF-TAPPING 30MM

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A202830120·20mm H x 28mm W x 30mm L x 12 degrees

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A202830150·20mm H x 28mm W x 30mm L x 15 degrees

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A20283080·20mm H x 28mm W x 30mm L x 8 degrees ALIF

    ELECTROCARDIOGRAPH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PELVIC MUSCLE THERAPY

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 30, 2025

    UNK

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·October 17, 2008

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code DHA·August 11, 2011

    RELIANCE SYNERGY WASHER

    FDA Adverse Event
    STERIS CANADA CORPORATION·Product code MEC·July 2, 2013

    SURGUARD3 SAFETY HYPODERMIC NEEDLE

    FDA Adverse Event
    Injury ·TERUMO PHILIPPINES CORPORATION·Product code FMI·December 23, 2025

    SURGUARD3 SAFETY HYPODERMIC NEEDLE

    FDA Adverse Event
    Injury ·TERUMO PHILIPPINES CORPORATION·Product code FMI·December 23, 2025

    SURGUARD2 SAFETY HYPODERMIC NEEDLE

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code MEG·November 17, 2025

    SURGUARD3 SAFETY HYPODERMIC NEEDLE

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FMI·December 23, 2025

    ETHICON

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAL·April 10, 2026

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    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

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020