BEUDAMED
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    iSyncWave

    FDA UDI
    iMediSync, Inc.·08800108500363·iSyncWaveTM is a wireless EEG measurement devic...

    TITE-FIT WIDE/TAPERED TITE-FIT WIDE

    FDA UDI
    HI-TEC IMPLANTS LTD.·07290110722661·IMPLANT SCREW

    RADREX-I, SW V4.00 MODEL DRAD-3000E

    FDA 510(k)
    FDA Class 2 ·Radiology

    buddy,230V SYSTEM

    FDA UDI
    BELMONT INSTRUMENT CORPORATION·00896128002732·buddy, 230V SYSTEM, ITALIAN, SWITZERLAND CORD

    AUTO SUTURE POWERED LDS ISW

    FDA Adverse Event
    Malfunction ·UNITED STATES SURGICAL CORP.·Product code GAG·June 27, 1996

    MENTOR SMOOTH ROUND SALINE

    FDA Adverse Event
    Injury ·MENTOR WORLDWIDE LLC·Product code FWM·September 7, 2021

    VARADY VARIX EXTRACTOR W/HOOK 180MM

    FDA Adverse Event
    Malfunction ·AESCULAP AP & CO. KG·Product code GAI·March 4, 2015

    UNK MAMMARY IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FWM·January 30, 2023

    ALLURA XPER FD

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·October 30, 2025

    CARETOUCH

    FDA Adverse Event
    Injury ·TIANJIN EMPECS MEDICAL DEVICE CO., LTD.·Product code NBW·June 20, 2023

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 14, 2008

    OVERPATCH

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code KGX·April 17, 2023

    UNKNOWN

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 13, 2012

    SOFT CUP

    FDA Adverse Event
    Injury ·THE FLEX COMPANY·Product code HHE·March 15, 2018

    DREAMSTATION

    FDA Adverse Event
    Injury ·PHILIPS / RESPIRONICS, INC.·Product code BZD·July 18, 2022

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·December 30, 2013

    EONC

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·October 30, 2013

    EPIDURAL CATHETERIZATION SETS

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code BSO·June 14, 2021

    (1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN): 11314237 (2) Atellica Data Manager software version 1.1 Siemens Material Number (SMN): 11316888 Product Usage: are clinical laboratory information modules which consolidate test orders and test results, provide test ordering and priority routing information to automation, apply rules to test orders and auto-verification rules for test results, and provide integrated management of quality control of test system.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code N/A·May 15, 2020

    (1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management System software version 16.0.3 Siemens Material Number (SMN): 11314337 Product Usage: are clinical laboratory information modules which consolidate test orders and test results, provide test ordering and priority routing information to automation, apply rules to test orders and auto-verification rules for test results, and provide integrated management of quality control of test system.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code N/A·May 15, 2020