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

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    Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)

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

    Procedure Products Needle

    FDA UDI
    PROCEDURE PRODUCTS, INC.·B1602118271·Seldinger Needle, 18ga x 7cm

    Procedure Products Needles

    FDA UDI
    PROCEDURE PRODUCTS, INC.·B160211827P1·18 GA needle, 7cm, BSDN, with Plug

    GSI VIEWER WITH VUE OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    ORTELIUS 800

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 29, 2014

    DEPUY ASR FEM IMPLANT SZ 47

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KXA·August 10, 2011

    SETROX S 60

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVN·July 8, 2013

    DEKA MOTUS AZ

    FDA Adverse Event
    Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·March 8, 2024

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021