91 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the biliary tract (common bile duct, cystic duct, and hepatic duct).
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code FBN·August 31, 2020
Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera system, light source, TV monitor, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the biliary tract (common bile duct, cystic duct, and hepatic duct).
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·October 28, 2020
BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
FDA Enforcement
Class II
·Terminated·BIOTRONIK Inc·April 28, 2021
BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
FDA Recall
Terminated
·BIOTRONIK Inc·Product code MRM·March 8, 2021
BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
FDA Enforcement
Class II
·Terminated·BIOTRONIK Inc·April 28, 2021
BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
FDA Recall
Terminated
·BIOTRONIK Inc·Product code LWS·March 8, 2021
Stratus(R) CS Acute care(TM) NT - proBNP TestPak reagent (CPBNPM) The Stratus(R) CS Acute care(TM) NT - proBNP method (pBNP) is an in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT0proBNP) in heparinized plasma. In individuals suspected of having congestive heart failure (CHF), measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the risk stratification of patient with acute coronary syndrome and heart failure.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code NBC·April 5, 2012
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
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
Opthalmic Laser, product number 8065-5000-1
FDA Recall
Terminated
·Alcon Research, Ltd.·Product code HQF·April 9, 2004
Model LightLas 532 Opthalmic Photocoagulator Laser
FDA Recall
Terminated
·LightMed USA Inc·Product code HQF·November 11, 2003