BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E ADULT DUAL LIMB CIRCUIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 2, 2026

    SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB

    FDA Adverse Event
    Injury ·BD MEDICAL - DIABETES CARE·Product code FMF·July 23, 2020

    MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    POLARIS SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 4, 2024

    1ML BD SAFETYGLIDE¿ TB SYRINGE, 27G X 0.5" BD¿ PERMANENTLY ATTACHED NEEDLE

    FDA Adverse Event
    Injury ·BD MEDICAL - DIABETES CARE·Product code FMF·March 1, 2017

    STEALTHSTATION S7 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·May 29, 2013

    ATTAIN STARFIX

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DTB·June 16, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·August 21, 2008

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015