11 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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AquaLiner Hydrophilic Guidewire 0.035" X 180cm, Angle / Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
FDA Enforcement
Class II
·Terminated·Nipro Medical Corporation·October 31, 2012
AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
FDA Enforcement
Class II
·Terminated·Nipro Medical Corporation·October 31, 2012
AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
FDA Enforcement
Class II
·Terminated·Nipro Medical Corporation·October 31, 2012
AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
FDA Enforcement
Class II
·Terminated·Nipro Medical Corporation·October 31, 2012
AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
FDA Enforcement
Class II
·Terminated·Nipro Medical Corporation·October 31, 2012
Jelco, Hypodermic needle Pro¿ needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx Only, Sterile EO.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·July 12, 2017
Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only
FDA Enforcement
Class II
·Ongoing·Nipro Medical Corporation·December 17, 2025
Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case. The Nipro¿ Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal access to the patient s blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge.
FDA Enforcement
Class II
·Terminated·Nipro Medical Corporation·May 23, 2018
NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set A disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis. Compatible for use with Fresenius 2008H, 2008K/K2 and 2008T dialysis machines.
FDA Enforcement
Class II
·Terminated·Nipro Medical Corporation·January 20, 2016
NIPRO Safe Touch Safety Scalp Vein Set
FDA Enforcement
Class II
·Terminated·Nipro Medical Corporation·June 25, 2014
Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood.
FDA Enforcement
Class II
·Terminated·Nipro Medical Corporation·November 4, 2015