BEUDAMED
    10 results · 26ms · Sources: EU EUDAMED, US FDA

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    EQUIPMENT/MATERIAL DECONTAMINATING KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    AXXENT RADIATION SHIELD - RIGID

    FDA 510(k)
    FDA Class 2 ·Radiology

    SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 11, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·November 22, 2010

    MYNX ACE 6F/7F VASCULAR CLOSURE DEVICE

    FDA Adverse Event
    Injury ·ACCESSCLOSURE, INC.·Product code MGB·July 2, 2014

    3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·October 17, 2012

    VITEK® 2 AST-GP67 TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC·Product code LQL·February 22, 2017

    3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code DQO·September 28, 2012

    Philips Zenition 70, Model Number: 718133

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024