BEUDAMED
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    ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

    FDA Recall
    Terminated ·Aesculap Implant Systems LLC·Product code LXH·July 13, 2020

    Clinical Chemistry ICT Calibrator, List Number: 1E46-02, Abbott Labs, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code CGZ·September 26, 2007

    Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthen the abdominal muscles.

    FDA Recall
    Terminated ·Pinook-Usa·Product code NGX·May 23, 2013

    Pinook Mini Massager Distributed by www.pinookusa.com. Used to strengthen the abdominal muscles.

    FDA Recall
    Terminated ·Pinook-Usa·Product code NGX·May 23, 2013

    Peregrine 20 GA Endo Ocular Adjustable Laser Probe

    FDA Recall
    Terminated ·Peregrine Surgical Ltd·Product code HQF·July 19, 2010

    Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek Multicolor Laser photocoagulator Model MC-500 is indicated for use in retinal photocoagulation for treatment of ocular fundus diseases.

    FDA Recall
    Terminated ·Nidek Inc·Product code HQF·October 24, 2012

    STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.

    FDA Recall
    Open, Classified ·Diagnostica Stago, Inc.·Product code KFF·July 21, 2025

    Ellex Solo LT5106-S ophthalmic laser (not sold in USA)

    FDA Recall
    Terminated ·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011

    Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xpress is intended to be used during endodontic therapy to fill the root canal of a tooth.

    FDA Recall
    Terminated ·Ormco/Sybronendo·Product code KIF·August 31, 2016

    Ellex Integre Duo, Model No: LP1RG - Ellex Medical PTY, LTD 82 Gilbert Street, Adelaide, S.A. 5000, AUSTRALIA. (The Integre Duo is a dual-wavelength surgical photocagulator laser intended for use in a clinic, outpatient clinic, or a retinal specialist's office. )

    FDA Recall
    Terminated ·Ellex USA·Product code HQF·June 13, 2007

    Ellex Solitarie Opthalmic Laser System, Model No: LP 4532 - Ellex Medical PTY, LTD 82 Gilbert Street, Adelaide, S.A. 5000, AUSTRALIA.

    FDA Recall
    Terminated ·Ellex USA·Product code HQF·June 13, 2007

    Sealapex Express (Part Number: 33639), root canal filling material. Manufactured by SybronEndo, Glendora, CA. Intended as a root canal filling material that is used in conjunction with gutta percha or silver endodontic points.

    FDA Recall
    Terminated ·Sybron Dental Specialties·Product code KIF·February 23, 2009

    Ellex Motorised Safety Filter, Zeiss; Model number 6339585. Intended for photocoagulation.

    FDA Recall
    Terminated ·Ellex Medical Pty Ltd·Product code HQF·February 11, 2009

    Motorised Safety Filter, Wild; Model number 6339590. Intended for photocoagulation.

    FDA Recall
    Terminated ·Ellex Medical Pty Ltd·Product code HQF·February 11, 2009

    Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea. Patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea. In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty. In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting.

    FDA Recall
    Terminated ·Carl Zeiss Meditec AG Carl Zeiss Promenade 10 Jena Germany·Product code HQF·February 3, 2014

    Ellex Super Q LQP3106 ophthalmic laser

    FDA Recall
    Terminated ·Ellex Medical Pty Ltd·Product code HQF·February 15, 2011

    MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.

    FDA Recall
    Terminated ·Nidek Inc·Product code HQF·June 9, 2014

    Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the laser delivery head. The filter prevents transmission of treatment laser light to physician eyes while the aiming beam to remain visible. .

    FDA Recall
    Terminated ·Laserex Systems Inc.·Product code HQF·February 1, 2016

    ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311R

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code KFF·February 3, 2023

    HemosIL LMW Heparin Controls; Part Number: 0020300200;

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code KFF·February 3, 2025