BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    MAMMODIAGNOST DR

    FDA 510(k)
    FDA Class 2 ·Radiology

    MYSTIQUE® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K110532101·MYSTIQUE® MB RT RX 022 U 5-5/L3-3 CS HK

    BD VISIDRAPE OPHTHALMIC DRAPES; BD VISIFLEX INCISE DRAPE

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

    VERSACLOSE, MODEL VC-200-01

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

    BD CONNECTA¿ STOPCOCK

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·December 31, 2018

    TELAMON FUSION DEVICE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code MAX·August 5, 2016

    TELAMON® FUSION DEVICE

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·August 3, 2012

    TELAMON® FUSION DEVICE

    FDA Adverse Event
    Injury ·MSD DEGGENDORF MFG·Product code MAX·August 3, 2012

    AUTOPLEX SYSTEM WITH VERTAPLEX HV W/O NEEDLES

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-PUERTO RICO·Product code JDZ·May 14, 2013

    RESERVOIR 1.8ML

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code FRN·September 23, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 1, 2011

    IMMULITE® 2000 3GALLERGY SPECIFIC IGE

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·December 11, 2024

    IMMULITE 2000 3GALLERGY SPECIFIC IGE UNIVERSAL KIT (SPE)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·October 1, 2022

    Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·August 30, 2017

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024