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

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    DIMENSION DRUG CALIBRATOR, MODEL DC22B

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Endo Carry-on Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964153174·Endo Carry-on Procedure Kit contains Basin, Spo...

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040013113·Zirlux 16+ D2 98.5X10

    QUICK-SET

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 10, 2025

    READERS.COM

    FDA UDI
    FGX INTERNATIONAL INC.·00192304063178·

    READERS.COM

    FDA UDI
    FGX INTERNATIONAL INC.·00192304063154·

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361010715·PedFuse Reset, SLD, 7.0mm x 35mm

    READERS.COM

    FDA UDI
    FGX INTERNATIONAL INC.·00192304063093·

    READERS.COM

    FDA UDI
    FGX INTERNATIONAL INC.·00192304063116·

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0112350·Tap, 7.50mm, Fixed Sleeve

    QUICK SET

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 8, 2025

    SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    IVS TUNNELLER

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

    BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·July 30, 2021

    VERTEBRAL SPACER-TR 10MMX27MM 11MM HEIGHT

    FDA Adverse Event
    Malfunction ·SYNTHES ELMIRA·Product code MQP·February 20, 2013

    ARTICULATING LINEAR CUTTER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·March 19, 2013

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·March 8, 2011

    AFFINITY DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2008

    Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·November 24, 2021

    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