BEUDAMED
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    CCD ENDOSCOPE AND ATTACHMENTS

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

    Ceramco® iC

    FDA UDI
    Dentsply International Inc.·D00148012470·2G Wide VS0

    ACUMED

    FDA UDI
    Acumed LLC·10806378047862·Plate Cutter Jaw Replacement Assy

    Intraoral Sensor

    FDA 510(k)
    FDA Class 2 ·Radiology

    TM-400

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ENDOPATH ETS FLEX

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·December 17, 1997

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 8, 2014

    INTERSTIM II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code EZW·October 23, 2012

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·August 16, 2010

    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