BEUDAMED
    12 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 ×

    TRUSCOPE SERIES PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Oticon

    FDA UDI
    Oticon A/S·05707131256089·NERA PRO, BTE 13 WL 85 STG

    ArgenZ HT+ 98x30 ML D4B

    FDA UDI
    ARGEN CORPORATION, THE·D818131763·Dental porcelain/ceramic restoration kit

    DIOPSYS NOVA VEP VISION TESTING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    PATHASSIST LIGHT FIBER

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    RELOAD FOR 60MM ECHELON

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

    VERCISE GENUS?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code PJS·November 17, 2025

    OT VERIO2 METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 8, 2016

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    ASKU

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

    EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code KRH·August 21, 2008

    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