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

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    ORTHOPEDIC SALVAGE SYSTEM- OSS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REPROCESSED ENDOSCOPIC ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CORDLESS COMPACT MOBILE X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·April 11, 2013

    SULFA HEXA FLUORIDE (SF6)

    FDA Adverse Event
    Injury ·ALCON LABORATORIES, INC.·Product code LPO·May 9, 2008

    UNKNOWN DEPUY ASR HIP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 7, 2011

    NFLEX CURVED ROD 60MM-STERILE

    FDA Adverse Event
    Injury ·SYNTHES ELMIRA·Product code NQP·March 31, 2016

    Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·August 8, 2012

    High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·August 8, 2012

    Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·August 8, 2012

    Pinnacle Destination Guiding Sheath, 7 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lots ME07 & MF12, 510(k) K052185 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.

    FDA Recall
    Terminated ·Terumo Medical Corporation·Product code DYB·June 24, 2010

    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