BEUDAMED
    18 results · 20ms · Sources: EU EUDAMED, US FDA

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    AURIS AEP

    FDA 510(k)
    FDA Class 2 ·Neurology

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890124150·Zirlux Shading Liquid - Effects, graphite, 30ml

    Battalion

    FDA UDI
    ALPHATEC SPINE, INC.·00840967187112·Battalion, LLIF Trial, 10°, 24 mm Wide, 15 mm X...

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0120150·Assembly, Screwdriver, Polyaxial, Lockable

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0134150·Trial, TLIF, 27L OB STR 7Deg, 15mm

    ISODAN

    FDA 510(k)
    FDA Class 2 ·Dental

    POWERDRIVE 350 OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·August 9, 2021

    SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·July 21, 2021

    SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·July 21, 2021

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·March 20, 2013

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·March 9, 2011

    PRECISION XTRA/OPTIUM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·March 11, 2008

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·December 21, 2017

    PANEL PHOENIX NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·December 22, 2023

    OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·June 26, 2024

    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

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019