BEUDAMED
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    OMNIGUIDE BEAMPATH CO2 MARK III WAVEGUIDE FIBER WITH LOW PROFILE/LOW LOSS TIP

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T

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

    PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 26, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 16, 2014

    STENOSCOP

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·May 4, 2011

    Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.

    FDA Enforcement
    Class II ·Ongoing·Genesee BioMedical, Inc.·June 6, 2018

    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