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

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    EVERON CENTRAL DISPLAY STATION (CDS)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    2.7mm/2.0mm Drill Sleeve

    FDA UDI
    Osteocentric Technologies, Inc.·00816950028441·2.7mm/2.0mm Drill Sleeve

    Tru-Arch Ni-Ti

    FDA UDI
    ORMCO CORPORATION·00889989028447·NITI CR TRU-ARCH 16x22 LWR MED-BP/100

    SCISSORS OPER STR S/B 6"

    FDA UDI
    W.H. Holden, Inc.·D9281105210·

    MYSTIQUE® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K110531101·MYSTIQUE® MB RT RX 018 U5-5/L3-3 CS HK

    MYSTIQUE® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K110531111·MYSTIQUE® MB RT RX 018 U 5-5/L3-3 CS-BC HK

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964080999·The ENDO CARRY-ON Procedure Kit contains all of...

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·June 26, 2012

    NICOLET VERSALAB

    FDA 510(k)
    FDA Class 2 ·Radiology

    COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD SUREPREP¿ CAPILLARY TUBES- PLAIN

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code GIO·May 20, 2022

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 14, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 23, 2014

    SENSORMEDICS

    FDA Adverse Event
    Malfunction ·CAREFUSION 207, INC.·Product code LSZ·May 25, 2011

    AEQUALIS STEM FOR FRACTURE D.6.5 HA-COATED

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·January 5, 2026

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·July 2, 2012

    TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non- modulated (non-IMRT/3 dimensional conformal) format in accordance with the physicians prescribed and approved plan.

    FDA Enforcement
    Class II ·Terminated·Accuray Incorporated·January 3, 2018

    FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth

    FDA Enforcement
    Class II ·Ongoing·Envisiontec US Llc·February 23, 2022

    FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth

    FDA Enforcement
    Class II ·Ongoing·Envisiontec US Llc·February 23, 2022

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016