BEUDAMED
    17 results · 20ms · Sources: EU EUDAMED, US FDA

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    Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814206·GENUMEDI PT SILVER L III

    HairCheck-DT (Cocaine)

    FDA UDI
    Quest Diagnostics·00868586000216·HairCheck-DT (Cocaine) is an ELISA test kit use...

    Geneva

    FDA UDI
    Nucletron B.V.·08717213056145·Interstitial Ovoid 20mm 1

    ELITE PLUS S2 FLANGED HI OFS

    FDA Adverse Event
    Malfunction ·DEPUY INTERNATIONAL, LTD.·Product code JDI·September 5, 2002

    ACCESS EPO ASSAY

    FDA 510(k)
    FDA Class 2 ·Hematology

    CHALLENGE-EVER

    FDA 510(k)
    FDA Class 1 ·Dental

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·July 28, 2022

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·July 7, 2011

    CAPSUREFIX MRI SURESCAN

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

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 10, 2008

    EDI BZO Uncut Sheet - Cup*, Item No. 160170

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·June 7, 2023

    ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    Precise Treatment Table. To be used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 17, 2013

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 2014

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014