BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4

    FDA 510(k)
    FDA Class 2 ·Radiology

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450560518·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450547380·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450457139·

    CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    BD DIRECTIGEN FLU A+B

    FDA 510(k)
    FDA Class 2 ·Microbiology

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·January 9, 2014

    TELIGEN

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code LWS·April 29, 2013

    GRANUFLO

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 5, 2014

    UNKNOWN PRODUCT

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS LIMERICK·Product code LOD·May 5, 2011

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code LMG·June 24, 2025

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·June 24, 2025

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018