BEUDAMED
    19 results · 31ms · Sources: EU EUDAMED, US FDA

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    Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.

    FDA Enforcement
    Class III ·Terminated·Zimmer Surgical Inc·May 20, 2015

    Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc., Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. Indicated for cemented use only.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·December 13, 2017

    Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. Indicated for cemented use only.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·December 13, 2017

    Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; osteoarthritis; post traumatic arthritis, avascular necrosis; femoral and neck fractures; osteomyelitis; fracture, dislocation of the hip; and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or girdlestone resection.

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew Inc·March 5, 2014

    Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons.

    FDA Recall
    Terminated ·Arthrex, Inc.·Product code HRS·January 11, 2016

    Shower Seat, Non-rotating, Catalog number 727152000

    FDA Recall
    Terminated ·Nutech Manufacturing Corp·Product code IKX·July 9, 2009

    Bath Safe Adjustable Transfer Bench, Catalog numbers 727142500, 727142501, and MDS86960R

    FDA Recall
    Terminated ·Nutech Manufacturing Corp·Product code IKX·July 9, 2009

    Shower Seat, Rotating, Catalog number 727152100

    FDA Recall
    Terminated ·Nutech Manufacturing Corp·Product code IKX·July 9, 2009

    Bath Safe Adjustable Shower Seat, With Back, Catalog number 727142101

    FDA Recall
    Terminated ·Nutech Manufacturing Corp·Product code IKX·July 9, 2009

    Bath Safe Adjustable Shower Seat, With Arms and Back, Catalog numbers 727142120, 727142121, 727142124, and MDS89755R

    FDA Recall
    Terminated ·Nutech Manufacturing Corp·Product code IKX·July 9, 2009

    Bath Safe Adjustable Shower Seat, With Arms, Model numbers 727142020, 727142021, and MDS89750R

    FDA Recall
    Terminated ·Nutech Manufacturing Corp·Product code IKX·July 9, 2009

    Bath Safe Adjustable Shower Seat, Without Back and Arms, Catalog number 727142001

    FDA Recall
    Terminated ·Nutech Manufacturing Corp·Product code IKX·July 9, 2009

    UniCel DxI 800 and 600 Access Immunoassay Systems, UniCel DxC 880i, 860i, 660i, and 680i SYNCHRON Access Clinical Systems with Dxl System Software versions 4.2 or 4.2.1. In vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentrations found in human body fluids.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code JJE·October 28, 2009

    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

    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

    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

    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

    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