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

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    AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CANNULA & CATHETER

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY GMBH·Product code DWF·April 22, 2025

    ComfortGel Blue

    FDA UDI
    Respironics, Inc.·00606959021020·ComfortGel Blue Full Mask, Small, China

    PMMA disc

    FDA UDI
    Dentsply International Inc.·D00180818200·

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587L081820120·8mm H x 18mm W x 20mm L XLIF Trial 12 degree Lo...

    General Instrument

    FDA UDI
    ALPHATEC SPINE, INC.·00840180505076·PLIF/TLIF Endlplate Scraper, Up-Angled, 12mm

    DENTORIUM CONVERTIBLE ACRYLIC

    FDA 510(k)
    FDA Class 2 ·Dental

    AART SILICONE CARVING BLOCK

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 29, 2013

    ASTRA TECH

    FDA Adverse Event
    Injury ·ASTRA·Product code DZE·May 5, 2011

    PUMP MMT-722NAB PRDGM INS V2.2 BL EN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·July 23, 2008

    GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015