28 results
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10ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·April 23, 2020
ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2020
AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
FDA Recall
Terminated
·Avanos Medical, Inc.·Product code FRN·April 24, 2023
AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507
FDA Recall
Terminated
·Avanos Medical, Inc.·Product code FRN·April 24, 2023
AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
FDA Enforcement
Class II
·Terminated·Avanos Medical, Inc.·June 14, 2023
AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507
FDA Enforcement
Class II
·Terminated·Avanos Medical, Inc.·June 14, 2023
P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Use Only
FDA Enforcement
Class II
·Terminated·Paragon 28, Inc.·December 18, 2019
P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Use Only
FDA Recall
Terminated
·Paragon 28, Inc.·Product code PLF·September 28, 2018
Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
FDA Recall
Terminated
·Medical Action Industries Inc·Product code OVN·June 12, 2014
ClearSight(TM) 1-Day (ocufilcon D) Toric 30 daily disposable contact lenses for astigmatism --- Name and Address on Label: CooperVision Hamble, SO31 4RF, UK, and Scottsville, NY 14546 USA --- Each lens is supplied sterile in a blister containing buffered saline solution. The blister is labeled with the base curve, diameter, dioptric power, manufacturing lot number, and expiration date of the lens. ClearSight contact lenses are made from a material containing 55% water and 45% ocufilcon D, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue 6) which is added to make the lens more visible for handling. When placed on the cornea in its hydrated state, the ClearSight" (ocufilcon D) Soft (Hydrophilic) Contact Lens acts as a refracting medium to focus light rays on the retina.
FDA Recall
Terminated
·CooperVision Inc.·Product code MVN·August 28, 2009
Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
FDA Recall
Terminated
·Medical Action Industries Inc·Product code OVN·June 12, 2014
McKesson Medi-Pak, Laceration Trays with Cotton O.R. Towels, Sterile, Single Use, Latex Free, 20 Each per Case, Rx only, Distributed by: McKesson Medical Surgical, Inc., Richmond, VA 23228
FDA Recall
Terminated
·Medical Action Industries Inc·Product code OVN·June 12, 2014
Outer Carton labeled in part:" 1-DAY ACUVUE MOIST BRAND CONTACT LENSES WITH LACREON FOR ASTIGMATISM***Contact Lenses for Daily Wear***D -1.50***-1.25 100***2016/07***BC 8.5***DIA 14.5***Made in USA***LOT B00BVTN0VS***" Individual Lenses labeled in part: "***1-DAY ACUVUE MOIST FOR ASTIGMATISM WITH LACREON***BC 8.5***DIA 14.5***AXIS -1.75 -0.75***080***2016/06***LOT B00BSBH***" It is intended for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with not diseased eyes who may have 1.00D or less of astigmatism.
FDA Recall
Terminated
·Johnson & Johnson Vision Care, Inc.·Product code MVN·December 1, 2011
Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
FDA Recall
Terminated
·Medical Action Industries Inc·Product code OVN·June 12, 2014
Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx ONLY --- Coopervision Shamble, SO 31 4 RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA daily use disposable contact lenses
FDA Recall
Terminated
·CooperVision Inc.·Product code MVN·November 20, 2013
Port-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
FDA Recall
Terminated
·Medical Action Industries Inc·Product code OVN·June 12, 2014
Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc., Arden, NC.
FDA Recall
Terminated
·Medical Action Industries Inc·Product code OVN·June 12, 2014
clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dopters that does not interfere with visualacuity. Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UVblocker help protect against transmission of harmful UV radiation to the cornea andinto the eye.
FDA Recall
Terminated
·CooperVision Inc.·Product code MVN·February 21, 2018
ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses for astigmatism, STERILE, Rx only --- CooperVision Hamble, SO31 4RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA daily use disposable contact lenses for astigmatism
FDA Recall
Terminated
·CooperVision Inc.·Product code MVN·November 20, 2013
Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
FDA Recall
Terminated
·Medical Action Industries Inc·Product code OVN·June 12, 2014