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

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    ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)

    FDA 510(k)
    FDA Class 2 ·Hematology

    Artman Instruments

    FDA UDI
    Wise Linkers, LLC·D1272421271·Dental Root Extraction Elevators Set of 9 ARTMAN

    LCP

    FDA UDI
    Synthes GmbH·10886982168207·4.5MM LCP® PROXIMAL FEMUR HOOK PLATE 16 HOLES/3...

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776118419·Jacobs Chuck Drill Ø3.2mm, 42/127mm

    Avalign

    FDA UDI
    Provision·B504OM8532421270·

    Tecomet

    FDA UDI
    TECOMET INC.·00841435120808·Locking Pliers

    SMITH & NEPHEW MODULAR HIP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ELECSYS ESTRADIOL III CALCHECK 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GLIDEWELL HT IMPLANT Ø3.5 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·May 13, 2025

    GLIDEWELL HT IMPLANT Ø3.5 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 18, 2026

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 2, 2023

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·November 10, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2013

    PKG, NEEDLE HOLDER, STRIAGHT, P/N 0250080340. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·July 16, 2014

    VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field Extensions Azurion 7 series (722136), Allura Xper R9 (722303). The product is software, used during an endovascular intervention procedure.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·February 19, 2020