BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    AIGIS RX R PM/ AIGIS RX R ICD

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    A.S.A.P.® Indirect+ Extraoral/HP Final Polisher Refill

    FDA UDI
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172016988·Dental Abrasive Disk

    A.S.A.P.® Indirect+ Extraoral/HP Final Polisher Refill

    FDA UDI
    DEN-MAT HOLDINGS, LLC·00359883006129·Dental Abrasive Disk

    LINK Instruments - Rasps, compressors and broaches

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575286652·Orthopaedic prosthesis instrument, reusable - G...

    LINK Instruments - Rasps, compressors and broaches

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575286645·Orthopaedic prosthesis instrument, reusable - G...

    MODIFICATION TO HIOX

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    INVADER FACTOR II

    FDA 510(k)
    FDA Class 2 ·Hematology

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·April 13, 2022

    THUNDERBEAT

    FDA Adverse Event
    Malfunction ·OLYMPUS AMERICA, INC.·Product code GEI·May 11, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

    9611500-2008-00026

    FDA Adverse Event
    Other ·Product code CBK·August 7, 2008

    CAPIOX RX OXYGENATOR

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DTZ·May 26, 2023

    OSSEOTITE TAPERED CERTAIN PREVAIL IMPLANT 4/3 X 13MM

    FDA Adverse Event
    Injury ·BIOMET 3I·Product code DZE·September 29, 2025

    CAPIOX RX OXYGENATOR

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·April 20, 2018

    CAPIOX RX OXYGENATOR

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·July 31, 2024

    CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DTZ·January 31, 2024

    CAPIOX®RX

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·December 9, 2024

    CAPIOX RX OXYGENATOR

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·July 5, 2018

    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