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

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    TUBE HOLDER

    FDA 510(k)

    VITROS

    FDA UDI
    ORTHO CLINICAL DIAGNOSTICS·10758750001156·VITROS Immunodiagnostic Products Anti-HCV Controls

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209124909·

    Forcep

    FDA UDI
    KOROS U.S.A., INC.·10840199533685·Delicate DeBakey Round Handle Forcep 1.2mm Tip,...

    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Dako North America Inc.·November 11, 2015

    ONTRAK TESTCUP 501, MODEL 3016633

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708; 851318704-708, 131218204

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 8, 2014

    CONSTELLATION VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·October 18, 2012

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 16, 2010

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024