BEUDAMED
    16 results · 22ms · 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 ×

    STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION

    FDA 510(k)
    FDA Class 2 ·Neurology

    INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5

    FDA 510(k)
    FDA Class 2 ·Radiology

    CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AP409 -PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FPA·December 18, 2025

    AP205 - INFUSION SET WITH NON-VENTED SPIKE, 1.2UM FILTER AND NEEDLE Y-SITE

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FPA·June 5, 2024

    AP210 - MICROBORE WITH NON-VENTED SPIKE AND 1.2UM FILTER

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FPA·June 6, 2024

    AP210 - MICROBORE WITH NON-VENTED SPIKE AND 1.2UM FILTER

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FPA·June 17, 2024

    AP403 - MICROBORE INFUSION SET WITH VENTED/NON-VENTED SPIKE

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FPA·March 31, 2026

    AP407 - INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER AND NEEDLELESS Y-SITE

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FPA·March 4, 2026

    VIDAS HCG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code JLW·November 26, 2020

    SENSOR ENLITE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·October 4, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

    1X2 CDP PM KIT

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·June 27, 2011

    VIDAS TSH

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code JLW·November 25, 2020

    VIDAS HCG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code JHI·August 19, 2021

    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