BEUDAMED
    21 results · 39ms · Sources: EU EUDAMED, US FDA

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    Allen Medical Systems PAL Pro Stirrups Catalog Number: A-10051-A1

    FDA Recall
    Terminated ·The OR Group, Inc. A Subsidiary of Hill-Rom Inc. One Post Office Square·Product code FWZ·June 2, 2003

    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 Recall
    Terminated ·Allen Medical Systems, Inc. One Post Office Square·Product code HST·February 28, 2013

    Allen C-Flex Head Positioning System non-invasive medical device used to support a patient's head during spine surgery Catalog Numbers: A-70700 and A-70701-2

    FDA Recall
    Terminated ·Allen Medical Systems, Inc. One Post Office Square·Product code CCX·November 16, 2011

    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 Recall
    Terminated ·Allen Medical Systems·Product code N/A·February 21, 2018

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

    FDA Recall
    Terminated ·Allen Medical Systems·Product code JEB·October 6, 2017

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

    FDA Recall
    Terminated ·Allen Medical Systems·Product code JEB·October 6, 2017

    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

    Allen A-91000 Shoulder Positioner

    FDA Recall
    Terminated ·Allen Medical Systems One Post Office Square·Product code FWZ·March 4, 2005

    Neuro Adapter 2 used with the Berchtold B-810 Surgical Table or Getinge USA Fortis Surgical Table Catalog No: MDTNA2

    FDA Recall
    Terminated ·Allen Medical Systems One Post Office Square·Product code FQO·July 12, 2004

    Allen Medical C-Flex, Polar Head Positioner Catalog Number: A-70700-A1 Product is a medical device used to maintain the position of an anesthetized patient during surgery.

    FDA Recall
    Terminated ·Allen Medical Systems, Inc. One Post Office Square·Product code CCX·November 27, 2007

    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 Recall
    Terminated ·Allen Medical Systems, Inc. One Post Office Square·Product code HST·January 3, 2017

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

    FDA Recall
    Terminated ·Allen Medical Systems, Inc. One Post Office Square·Product code HST·November 23, 2016

    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 Recall
    Terminated ·ICU Medical, Inc.·Product code DRS·September 27, 2016

    Richard-Allan Scientific Specimen Transportation System. 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

    FDA Recall
    Terminated ·Richard-Allan Scientific Company·Product code LDY·September 17, 2014