BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

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    NEUROSURGICAL HEADFRAME ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Neurology

    DELTRAN

    FDA UDI
    UTAH MEDICAL PRODUCTS, INC.·H6719025170·DELTRAN II, Disposable Pressure Transducer Syst...

    HEPARIN LOCK FLUSH SOLUTION 100 UNITS/ML

    FDA Adverse Event
    Death ·AMSINO MEDICAL USA·Product code NZW·June 3, 2008

    USS VAS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS

    FDA 510(k)
    FDA Class 1 ·Dental

    AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS (MN)·Product code OTP·June 30, 2014

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 8, 2013

    APOGEE

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·November 12, 2010

    HEPARIN 100U/ML

    FDA Adverse Event
    Death ·AMSINO·Product code NZW·March 7, 2008

    Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·November 12, 2025

    UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 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