BEUDAMED
    16 results · 32ms · Sources: EU EUDAMED, US FDA

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    FACET SCREW SYSTEM

    FDA 510(k)
    FDA Unclassified ·Unknown

    WHOLEY GUIDE WIRE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EBV VCA-P18 IGG ELISA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    GUIDE WIRE, SMOOTH-TIPPED, STERILE T2 HUMERUS Ø2,2X800 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·December 2, 2015

    GUIDE WIRE, BALL-TIPPED, STERILE T2 HUMERUS Ø2.5X800 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·December 2, 2015

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 24, 2013

    ATTAIN OTW

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DTB·June 16, 2011

    1 DAY ACUVUE MOIST

    FDA Adverse Event
    Injury ·VISTAKON·Product code LPL·August 20, 2008

    Single Shot Epidural Tray Catalog Number: 6183R1

    FDA Enforcement
    Class II ·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022

    MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS

    FDA Adverse Event
    Malfunction ·MENTOR TEXAS·Product code LCJ·October 20, 2020

    MENTOR CPX 4 BREAST TISSUE EXPANDER

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·May 24, 2022

    MENTOR CPX 4 BREAST TISSUE EXPANDER

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·June 27, 2024

    MENTOR CPX 4 BREAST TISSUE EXPANDER

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·December 9, 2022

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·January 21, 2022

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    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