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

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    Omnipod 5 SmartBolus Calculator

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OMNIPOD 5 CONTROLLER

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code QFG·July 21, 2022

    OMNIPOD 5 CONTROLLER

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code QFG·August 22, 2022

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114032·GIANNETTI MODIFIED J-CANNULA (PK/10)

    Oph. Cystotomes

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113721·CYSTOTOME CURVED 27GA

    KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ELECSYS DHEA-S CALCHECK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BD MAX¿ GBS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code NJR·June 7, 2023

    BD MAX¿ GBS

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code NJR·April 5, 2023

    BD MAX¿ GBS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code NJR·June 10, 2023

    BD MAX¿ GBS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code NJR·June 7, 2023

    BD MAX¿ GBS

    FDA Adverse Event
    Injury ·BECTON DICKINSON & CO. (SPARKS)·Product code NJR·June 7, 2023

    ANIMAS VIBE SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code OYC·March 21, 2016

    ANIMAS VIBE SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code OYC·March 21, 2016

    ANIMAS VIBE SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code OYC·March 21, 2016

    PROXIMATE ILS CURVED CIR STAPL

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GDW·October 10, 2008

    URETEX TO2 URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code OTN·April 4, 2013

    CAPSURE SENSE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    BARD Dynamic Deca Steerable, Product Number 201101; 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