BEUDAMED
    44 results · 10ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.

    FDA Enforcement
    Class II ·Terminated·Mizuho America, Inc.·December 4, 2013

    Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.

    FDA Enforcement
    Class II ·Terminated·Mizuho America, Inc.·December 4, 2013

    Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.

    FDA Recall
    Terminated ·Mizuho America, Inc.·Product code HCH·October 10, 2013

    Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.

    FDA Recall
    Terminated ·Mizuho America, Inc.·Product code HCH·October 10, 2013

    Olympus JF-160F duodenoscopes (Model NumberJF-160F)

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FET·May 11, 2018

    Olympus JF-140F duodenoscopes (Model NumberJF-140F)

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FET·May 11, 2018

    Olympus JF-160F duodenoscopes (Model NumberJF-160F)

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·June 27, 2018

    Olympus JF-140F duodenoscopes (Model NumberJF-140F)

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·June 27, 2018

    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

    Nicolet Elite 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.

    FDA Recall
    Terminated ·Natus Neurology Inc·Product code JAF·June 9, 2017

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

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

    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

    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