BEUDAMED
    16 results · 31ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DRG QUICKMIX

    FDA 510(k)
    FDA Class 2 ·Neurology

    GALEO HYDRO AND GALEO HYDRO J-TIP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 14, 2025

    MODIFIED KUGEL PATCH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·October 7, 2010

    MODIFIED KUGEL PATCH

    FDA Adverse Event
    Malfunction ·DAVOL INC.·Product code FTL·September 1, 2011

    MINICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·April 16, 2013

    UNKNOWN

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code HRY·June 16, 2008

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·April 18, 2011

    MODIFIED KUGEL PATCH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·June 27, 2013

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 28, 2017

    MODIFIED KUGEL PATCH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·May 25, 2016

    MODIFIED KUGEL PATCH

    FDA Adverse Event
    Injury ·DAVOL INC·Product code FTL·August 2, 2011

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015