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

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    ASO QUANTUM, ANTISTREPTOLYSIN O TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B58208011770·IMPACTOR

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209127412·

    BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ENDOPATH ETS FLEX

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·December 23, 1997

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 8, 2014

    UNK RIGHT REJUVENATE/ABG II HIP

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·October 17, 2012

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·July 27, 2007

    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

    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

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024