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

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    LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Oticon

    FDA UDI
    Oticon A/S·05707131256263·NERA PRO, MINIBTE 312 WL 85 SIL

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK, INC.·Product code MAX·May 9, 2019

    MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DATEX-OHMEDA HMEF 750

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DISPOSABLE EXTENSION CABLE

    FDA Adverse Event
    Malfunction ·REMINGTON MEDICAL, INC.·Product code DSA·March 20, 2014

    CORNERSTONE-SR TI-COATED CAGE SYSTEM

    FDA Adverse Event
    Malfunction ·MSD DEGGENDORF MFG·Product code ODP·October 11, 2018

    RELOAD FOR 60MM ECHELON

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 22, 2021

    INGEVITY

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVN·October 1, 2014

    TENSION FREE VAGINAL TAPE

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

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·June 16, 2011

    CORNERSTONE-SR TI-COATED CAGE SYSTEM

    FDA Adverse Event
    Malfunction ·MSD DEGGENDORF MFG·Product code ODP·September 7, 2017

    CORNERSTONE-SR® TI-COATED CAGE SYSTEM

    FDA Adverse Event
    Malfunction ·MSD DEGGENDORF MFG·Product code ODP·October 6, 2025

    CORNERSTONE-SR® TI-COATED CAGE SYSTEM

    FDA Adverse Event
    Malfunction ·MSD DEGGENDORF MFG·Product code ODP·October 8, 2024

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·October 9, 2020

    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