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

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    TOBRAMYCIN RIA KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Tobii Dynavox

    FDA UDI
    TOBII DYNAVOX LLC·07340074601448·SC TABLET PRO, SGD, WITH SNAP + CORE FIRST, STE...

    INTRA-AORTIC BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·June 19, 1998

    BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·May 8, 2014

    INRATIO2

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC.·Product code GJS·October 17, 2012

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 7, 2007

    Apollo (cold) Laser Desktop Control Units, Model AP2-DT. The Apollo IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and / or promoting relaxation of muscle.

    FDA Recall
    Terminated ·Pivotal Health Solutions·Product code ILY·December 17, 2014

    Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol, GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108. Biotene Mouth Spray is used for the treatment of dry mouth

    FDA Recall
    Terminated ·GlaxoSmithKline, LLC.·Product code LFD·October 17, 2013

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·March 22, 2023