BEUDAMED
    19 results · 36ms · Sources: EU EUDAMED, US FDA

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    NEWTRON P5, NEWTRON P5 B.LED

    FDA 510(k)
    FDA Class 2 ·Dental

    BD NANO¿ 2ND GEN PEN NEEDLES 4MM X 32G

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·February 17, 2022

    ELECSYS FERRITIN CALCHECK 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    R&D DESIGNATION AP-052-5

    FDA 510(k)
    FDA Class 2 ·Dental

    INFLATOR KIT 18INFKIT BALLOON

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code LRC·August 15, 2014

    BD NANO¿ 2ND GEN PEN NEEDLES 4MM X 32G

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·August 12, 2022

    BALLOON SEEKER

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code LRC·August 15, 2014

    BD NANO¿ 2ND GEN PEN NEEDLES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·June 17, 2022

    BD NANO¿ 2ND GEN PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·February 14, 2022

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code DTB·October 1, 2014

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·May 29, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 17, 2011

    BD NANO 2ND GEN PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·May 23, 2022

    Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.

    FDA Recall
    Terminated ·Zimmer Dental Inc·Product code DZE·January 6, 2014

    BD NANO¿ 2ND GEN PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·April 20, 2022

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code HBC·March 26, 2018

    Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.

    FDA Enforcement
    Class II ·Terminated·Zimmer Dental Inc·February 5, 2014

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015

    Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·January 24, 2018