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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TLIF

    FDA UDI
    Nuvasive, Inc.·00887517421920·TLIF Inserter, 11x25mm Angled Micro

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776209667·Visual Obturator with AI sheath scope lock

    SUPER CHAIR FOR KIDS BY ORION

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    VERMED A10021 RESTING EKG TAB ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POWERPACK

    FDA Adverse Event
    Malfunction ·ICC-NEXERGY·Product code IYN·September 3, 2013

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 27, 2025

    DORMA 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·March 16, 2022

    Widex

    FDA UDI
    Widex A/S·05706069553680·Widex UNIQUE U-FA (Titan grey ) 330, Telecoil, ...

    Widex

    FDA UDI
    Widex A/S·05706069564150·Widex UNIQUE U-FP (Titan grey ) 330, Telecoil, ...

    Widex

    FDA UDI
    Widex A/S·05706069556377·Widex D-FA P (Titan grey ) Dream 330, Telecoil,...

    Widex

    FDA UDI
    Widex A/S·05706069575668·Widex UNIQUE U-FM (Titan grey ) 330, RC coil

    UNKNOWN STRATA VALVE/SHUNT

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROSURGERY·Product code JXG·May 21, 2013

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·September 30, 2014

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code NIK·June 16, 2011

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    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