BEUDAMED
    13 results · 24ms · 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.

    Renovo Life Hard Carbon Coated Drill Bit

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    ProLift

    FDA UDI
    Life Spine, Inc.·00190837106263·Static Expandable Cage Trial, 10mm x 28mm x 12m...

    IMPLANT HANDPIECES

    FDA 510(k)
    FDA Class 1 ·Dental

    MYRAY HYPERION

    FDA 510(k)
    FDA Class 2 ·Dental

    BD A-LINE¿

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·March 14, 2024

    WARMER DRAPE

    FDA Adverse Event
    Malfunction ·MICROTEK DOMINICANA, S.A.·Product code LHC·March 1, 2016

    WARMER DRAPE

    FDA Adverse Event
    Malfunction ·MICROTEK DOMINICANA, S.A.·Product code LHC·March 1, 2016

    BD A-LINE¿

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 30, 2024

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·October 8, 2014

    ATTAIN OTW

    FDA Adverse Event
    Injury ·MPRI·Product code LWP·June 7, 2013

    COULTER LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·June 24, 2011

    Medical Linear Accelerator

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 14, 2016

    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