BEUDAMED
    18 results · 20ms · Sources: EU EUDAMED, US FDA

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    Mobility Scooter

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Lumex

    FDA UDI
    GF HEALTH PRODUCTS, INC.·M36882202061·W/C CUSHION GEL FOAM 20X16X4

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694034746·1.2mm Neuro, Fast-Flap Delivery System

    OLYMPUS UROLOGY LASER FIBER WIRE

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM, S.P.A.·Product code GEX·December 9, 2022

    MEDTRONIC MINIMED PARADIGM INSULIN PUMPS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INTRAORAL CAMERA ME-15

    FDA 510(k)
    FDA Class 1 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 12, 2025

    MECHANICAL CHAIR/TRANSPORT CHAIR

    FDA Adverse Event
    GOODBABY·Product code INM·November 3, 2014

    ALYX COMPONENT COLLECTION SYSTEM

    FDA Adverse Event
    Injury ·AVENDIA FENWAL·Product code GKT·August 9, 2011

    RIATA ST OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2013

    AXS VECTA 074 CATH 132CM - CE

    FDA Adverse Event
    Injury ·STRYKER NEUROVASCULAR-CALIF·Product code QJP·July 24, 2024

    EVIS EXERA II COLONOVIDEOSCOPE

    FDA Adverse Event
    Malfunction ·AIZU OLYMPUS CO., LTD.·Product code FDF·December 13, 2022

    Stage-1 RDS Indexed Abutment for RDS Stage-1 Single Stage Implants Keystone s implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate abutment support for fixed bridgework.

    FDA Recall
    Terminated ·Keystone Dental Inc·Product code DZE·August 25, 2017

    Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants Keystone s implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate abutment support for fixed bridgework.

    FDA Enforcement
    Class II ·Terminated·Keystone Dental Inc·March 7, 2018

    Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2015

    LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA POR; and Custom devices Item Nos. 114754 114755 114744 114745 114704 114705 114756 114757 114714 114715 114746 114747 114706 114707 114758 114759 114716 114717 114748 114749 114708 114709 114718 114719 CP561429 CP561430 CP561431 CP561432 CP561442 CP561449 CP561488 CP561489 CP561709 CP561710 CP561714 CP561715 PM555203 Product Usage: Total Elbow Replacement

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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