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

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    MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Silverbolt/Mainframe

    FDA UDI
    Choice Spine, LP·10885862163639·

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361011590·PedFuse Respond, CNL, 7.0mm x 50mm

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0120500·Screwdriver, Assembled Screws SNI1

    InSePtion MIS Fixation System

    FDA UDI
    Kalitec Direct LLC·B07314K0120500·Inserter, All-In-One

    flamenco™ spinal fixation system

    FDA UDI
    Ulrich GmbH & Co. KG·04052536021512·flamenco rod, ø 5.5 mm, length 350 mm

    REFACTO LABORATORY STANDARD

    FDA 510(k)
    FDA Class 2 ·Hematology

    STA -CALIBRATOR HBPM/LMWH KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    T-SLING

    FDA Adverse Event
    Injury ·HERNIAMESH S.R.L.·Product code FTL·March 7, 2013

    ACCU-CHEK ® COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 9, 2011

    UNIPLATE SELF DRILLING SCREW, 12MM

    FDA Adverse Event
    Injury ·DEPUY SPINE, INC.·Product code KWQ·February 12, 2008

    IV SET TUR Y-TUBE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·April 8, 2020

    IV SET TUR Y-TUBE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·April 9, 2020

    ARCHITECT AFP

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND·Product code LOK·February 13, 2012

    ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral body and bone lesions.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 7, 2016

    Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 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