32 results
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49ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicated relative Blood Alcohol Concentration (BAC) at 0.02%, 0.04%, 0.05%, 0.06%, 0.08%, or 0.10% cut-off levels.
FDA Enforcement
Class III
·Terminated·Acon Laboratories, Inc.·August 5, 2015
Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicated relative Blood Alcohol Concentration (BAC) at 0.02%, 0.04%, 0.05%, 0.06%, 0.08%, or 0.10% cut-off levels.
FDA Recall
Terminated
·Acon Laboratories, Inc.·Product code DJZ·June 17, 2015
Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
FDA Enforcement
Class II
·Terminated·Alcon Research LLC·April 29, 2020
Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
FDA Recall
Terminated
·Alcon Research LLC·Product code HQC·July 25, 2018
Alcon/Grieshaber Morris ILM Forceps, Direct Action; Manual ophthalmic surgical instrument, Catalog Number: 641.22; Non-sterile/Reusable; Alcon Laboratories, Inc., Fort Worth, TX 76134.
FDA Recall
Terminated
·Alcon Research, Ltd·Product code HNR·March 7, 2008
Alcon 25 GA Total Plus Pak, Catalog/Item #8065750220; for use with ACCURUS Vitrectomy System; distributed by Alcon Laboratories, Inc., Fort Worth, TX 76134.
FDA Recall
Terminated
·Alcon Laboratories, Inc·Product code NGY·April 29, 2009
Alcon Custom-Pak, part #4917-54, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.
FDA Recall
Terminated
·Alcon Laboratories, Inc·Product code HNN·December 22, 2006
Alcon Custom-Pak, part #2638-17, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.
FDA Recall
Terminated
·Alcon Laboratories, Inc·Product code HNN·December 22, 2006
Alcon Custom-Pak, part #11148-02, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.
FDA Recall
Terminated
·Alcon Laboratories, Inc·Product code HNN·December 22, 2006
Alcon Custom-Pak, part #6515-51, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.
FDA Recall
Terminated
·Alcon Laboratories, Inc·Product code HNN·December 22, 2006
Alcon Custom-Pak, part #10975-02, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.
FDA Recall
Terminated
·Alcon Laboratories, Inc·Product code HNN·December 22, 2006
Alcon Vitrectomy 25 GA Custom Pak, Catalog/Item #10240-03, 11077-03, 11187-02 and 13305-01; distributed by Alcon Laboratories, Inc., Fort Worth, TX 76134.
FDA Recall
Terminated
·Alcon Laboratories, Inc·Product code NGY·April 29, 2009
LADARVision Excimer Laser System.
FDA Recall
Terminated
·Alcon Laboratories, Inc.·Product code LZS·August 1, 2005
PurePoint System Operator's Manual, Catalog Number 8065751131, Rev. B for use with the Alcon PurePoint Laser, Catalog Number 8065750597 Indicated for use in photocoagulation of both anterior and posterior segments of the eye.
FDA Recall
Terminated
·Alcon Laboratories, Inc.·Product code HQF·September 26, 2008
AcrySof ReSTOR Intraocular Lens
FDA Recall
Terminated
·Alcon Laboratories, Inc·Product code MFK·December 14, 2006
AcrySof ReSTOR Intraocular Lens
FDA Recall
Terminated
·Alcon Laboratories, Inc·Product code MFK·December 14, 2006
MONARCH II IOL Delivery System, Cartridge Model B, part #8065977758, packaged in pouches, 10 pouches/carton, and labeled in part ***Alcon Laboratories Fort Worth, Texas 76134 USA***for AcrySof IOLs*** The product is used for implanting intraocular lenses (IOLs) into the eye following cataract removal. Each cartridge is imprinted with the model type on the wing of the Monarch II cartridge which can be visually verified prior to use.
FDA Recall
Terminated
·Alcon Laboratories, Inc·Product code KYB·July 7, 2008
''Alcon Ladarwave CustomCornea Wavefront System'' Aberrometer software Version 7.91
FDA Recall
Terminated
·Alcon Laboratories, Inc.·July 21, 2003
AcrySof Intraocular Lens
FDA Recall
Terminated
·Alcon Laboratories, Inc·Product code MFK·December 14, 2006
ISPAN patient bracelet, given to patients post surgery to warn of further use of dinitrogen monoxide
FDA Recall
Terminated
·Alcon Laboratories, Inc·Product code LPO·November 18, 2003