145 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Guided system is an advanced surgical planning, imaging and guidance technology designed to provide greater accuracy and efficiency during cataract surgery. It allows eye surgeons to capture a high-resolution, diagnostic reference image of the patients eye pre-operatively, quickly determine an optimized surgical plan that enables surgeons to see all inclusions and alignment in real-time.
FDA Recall
Terminated
·Alcon Research, Ltd.·Product code NFG·March 1, 2016
UHF Grollman Pigtail Long Tip Non-wirebraid, 7FG, 110 cm, Angiographic Catheter, Sterile, Merit Medical.
FDA Recall
Terminated
·Merit Medical Systems, Inc·Product code DQO·November 5, 2003
Flixene IFG with Assisted Delivery Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Recall
Terminated
·Atrium Medical Corporation·Product code DSY·July 12, 2013
Flixene IFG Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Recall
Terminated
·Atrium Medical Corporation·Product code DSY·July 12, 2013
Flixene IFG Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·October 9, 2013
Flixene IFG with Assisted Delivery Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·October 9, 2013
Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5123-4) Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark
FDA Enforcement
Class II
·Terminated·Asante Solutions, Inc.·January 8, 2014
Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5229-4); Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
FDA Enforcement
Class II
·Terminated·Asante Solutions, Inc.·January 8, 2014
Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5246-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
FDA Enforcement
Class II
·Terminated·Asante Solutions, Inc.·January 8, 2014
Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or inside a Combination Kit (FG-5147-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical, Lejre, Denmark
FDA Enforcement
Class II
·Terminated·Asante Solutions, Inc.·January 8, 2014
Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5143-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark
FDA Enforcement
Class II
·Terminated·Asante Solutions, Inc.·January 8, 2014
Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5249-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
FDA Enforcement
Class II
·Terminated·Asante Solutions, Inc.·January 8, 2014
Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5127-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark
FDA Enforcement
Class II
·Terminated·Asante Solutions, Inc.·January 8, 2014
UNO 100 EM/EE Patient Lift
FDA Recall
Terminated
·Liko, Inc.·Product code FNG·September 24, 2004
Penner Manufacturing Patient Transfer/Lift System, Cascade Transfer, Models 380000-1 (white) and 380000-2 (gray). The firm name on the label is Penner Manufacturing Inc., Aurora, NE. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff.
FDA Recall
Terminated
·Penner Mfg Inc·Product code FNG·January 19, 2009
Penner Manufacturing Transfer Electric Pacific Chair with scale, Patient Transfer/Lift System, Models 394000-1. The firm name on the label is Penner Manufacturing Inc., Aurora, NE. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff.
FDA Recall
Terminated
·Penner Mfg Inc·Product code FNG·January 19, 2009
Penner Manufacturing Bariatric Patient Transfer/Lift System, Cascade Transfer, Models 382500-1 (right entry). The firm name on the label is Penner Manufacturing Inc., Aurora, NE. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff.
FDA Recall
Terminated
·Penner Mfg Inc·Product code FNG·January 19, 2009
Penner Manufacturing Transfer Electric Pacific Chair, Patient Transfer/Lift System, Models 393000-1. The firm name on the label is Penner Manufacturing Inc., Aurora, NE. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff.
FDA Recall
Terminated
·Penner Mfg Inc·Product code FNG·January 19, 2009
Penner Manufacturing Transfer Electric Superior end entry with scale, Patient Transfer/Lift System, Models 389000-1. The firm name on the label is Penner Manufacturing Inc., Aurora, NE. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff.
FDA Recall
Terminated
·Penner Mfg Inc·Product code FNG·January 19, 2009
Penner Manufacturing Transfer Electric Superior end entry, Patient Transfer/Lift System, Models 386000-1. The firm name on the label is Penner Manufacturing Inc., Aurora, NE. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff.
FDA Recall
Terminated
·Penner Mfg Inc·Product code FNG·January 19, 2009