342 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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Fancy i Color cosmetic lens, Contents: A pair of sterile soft color contact lens immersed in buffered isotonic saline solution, Size: B.C. 8.6mm DIA. 14.5mm. Dreamcon Co. LTD. Korea.
FDA Recall
Terminated
·Kim's Trading Inc·Product code LPM·May 17, 2010
UP & UP kids' power toothbrush
FDA Enforcement
Class II
·Terminated·Ranir Corporation·January 29, 2014
AVANOS MIC-KEY SF Gastrostomy Feeding Tube
FDA Enforcement
Class II
·Terminated·Avanos Medical, Inc.·September 23, 2020
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
FDA Enforcement
Class II
·Terminated·Aesculap Implant Systems LLC·July 27, 2022
Fresenius 2008T Series Hemodialysis System
FDA Enforcement
Class II
·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·January 25, 2017
Fresenius 2008K Series : Hemodialysis System
FDA Enforcement
Class II
·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·January 25, 2017
Fresenius 2008K2 Series : Hemodialysis System
FDA Enforcement
Class II
·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·January 25, 2017
Fresenius 2008K@home Series : Hemodialysis System
FDA Enforcement
Class II
·Terminated·Fresenius Medical Care Renal Therapies Group, LLC·January 25, 2017
TopCare Clifford THE BIG RED DOG power toothbrush for kids!
FDA Enforcement
Class II
·Terminated·Ranir Corporation·January 29, 2014
Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·February 7, 2018
AVANOS MIC-KEY SF Gastrostomy Feeding Tube
FDA Recall
Terminated
·Avanos Medical, Inc.·Product code KNT·July 29, 2020
Fresenius 2008T Series Hemodialysis System
FDA Recall
Terminated
·Fresenius Medical Care Renal Therapies Group, LLC·Product code KDI·December 21, 2016
Fresenius 2008K2 Series : Hemodialysis System
FDA Recall
Terminated
·Fresenius Medical Care Renal Therapies Group, LLC·Product code KDI·December 21, 2016
Fresenius 2008K Series : Hemodialysis System
FDA Recall
Terminated
·Fresenius Medical Care Renal Therapies Group, LLC·Product code KDI·December 21, 2016
Fresenius 2008K@home Series : Hemodialysis System
FDA Recall
Terminated
·Fresenius Medical Care Renal Therapies Group, LLC·Product code KDI·December 21, 2016
STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10232
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.
FDA Enforcement
Class II
·Terminated·B Braun Medical, Inc.·September 18, 2013
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
FDA Recall
Terminated
·Aesculap Implant Systems LLC·Product code LXH·November 18, 2020
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-100ES, 621-200ES, 621-300ES, and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.
FDA Enforcement
Class II
·Terminated·B Braun Medical, Inc.·September 18, 2013
Stryker Xia 3 Anti-Torque Key Manual Surgical Instrument; Catalog Number 48237026. Product Usage: : Reusable instrument used to aid in the final tightening of the spinal construct. Intended Use: The Anti-Torque Key allows the Torque Wrench to align with the tightening axis and maximizing the torque needed to lock the implant assembly during final tightening of the spinal construct.
FDA Recall
Terminated
·Stryker Spine·Product code NKB·January 12, 2012