BEUDAMED
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    SoftPath GUI Releases 3.17 through 4.1.0. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. Manufacture/Distribution Dates: Version 3.17.5 10/14/2003. Version 3.17.6 03/28/2003. Version 3.17.7 07/02/2003. Version 3.17.8 03/03/2004. Version 4.1.0 07/03/2003. Version 4.1.1 10/03/2003. Intended for use in the Pathology Lab for receiving and accessioning specimens, documenting tissue processing, producing material labels, generating final diagnostic reports, and creating billing and management reports for surgical, GYN, NON-GYN, and Autopsy cases.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code LNX·March 28, 2007

    SoftPath GUI version 3.17.6.3.1. SCC Soft Computer 34350 US Highway 19 N, Palm Harbor, FL 34684. Date of Manufacture: Version 3.17.6.3.1 06/03/2003.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code LNX·March 11, 2004

    CryoValve Allograft heart valve

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·January 30, 2003

    CryoValve Allograft heart valve

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·January 23, 2003

    SA BASE with SoftLab Version 3.1.4.x. Manufactured 03/2003. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. Intends to provide clients with an interface that links all clinical laboratory departments throughout the enterprise.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code JQP·June 1, 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

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012