BEUDAMED
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    MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM

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

    REMEL

    FDA UDI
    REMEL, INC.·00848838009228·Purple Broth w/1% Cellobiose w/DT 20/PK

    BIOSENSORS CENTRAL VENOUS CATHETER KITS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    AUTOTOME RX39

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code KNS·April 12, 2013

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    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY·Product code FCW·April 15, 2011

    OLYMPUS

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code FED·June 17, 2008

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012