BEUDAMED
    11 results · 18ms · Sources: EU EUDAMED, US FDA

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    Monaco

    FDA 510(k)
    FDA Class 2 ·Radiology

    ProLift

    FDA UDI
    Life Spine, Inc.·00190837137946·

    Pro Lift Instruments

    FDA UDI
    Life Spine, Inc.·00190837031237·

    OMRON MODEL 514N TYMPANIC THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SAFE'N'SOUND PASSIVE DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013

    STANDARD INSERT

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 30, 2011

    DrugSmart 10 Test Cup (PCP & MDMA), Item No. 61055D; DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·November 25, 2015

    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

    Medical Linear Accelerator

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