BEUDAMED
    7 results · 16ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    OPEN HEART KIT WITH 03ML FLUSH DEVICE FOR FLETCHER ALLEN HEALTH CARE, Item No. 46063-77 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 23, 2016

    F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning on OR table tops during spinal surgery. The system consists of a table top frame, arm supports,

    FDA Enforcement
    Class II ·Terminated·Allen Medical Systems·April 4, 2018

    Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.

    FDA Enforcement
    Class II ·Terminated·Allen Medical Systems·February 28, 2018

    Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.

    FDA Enforcement
    Class II ·Terminated·Allen Medical Systems·February 28, 2018

    Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016.

    FDA Enforcement
    Class II ·Terminated·Allen Medical Systems, Inc.·January 4, 2017

    Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders, non-invasive medical devices designed to attach to orthopedic fracture tables to aid clinical staff in applying traction to the leg of a patient during surgical procedures.

    FDA Enforcement
    Class II ·Terminated·Allen Medical Systems, Inc.·March 27, 2013

    Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usage: The Arthrex Lateral Decubitus Shoulder Positioner is intended to allow for the controlled manipulation of the arm and shoulder joint during arthroscopic surgical procedures.

    FDA Enforcement
    Class II ·Terminated·Allen Medical Systems, Inc.·February 22, 2017