75 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with Image1 SPIES D1 camera head, Product Model No. TH116 & TH115, and DC1 Video Mediastinoscope
FDA Recall
Terminated
·Karl Storz Endoscopy·Product code FET·June 20, 2016
Olympus JF-160F duodenoscopes (Model NumberJF-160F)
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code FET·May 11, 2018
Olympus JF-140F duodenoscopes (Model NumberJF-140F)
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code FET·May 11, 2018
Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.
FDA Recall
Terminated
·Fujifilm Medical Systems U.S.A., Inc.·Product code FET·June 30, 2015
Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
FDA Recall
Terminated
·Fujifilm Medical Systems U.S.A., Inc.·Product code FET·June 30, 2015
Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery.
FDA Enforcement
Class II
·Terminated·Vital Signs Devices, a GE Healthcare Company·November 28, 2012
Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery.
FDA Recall
Terminated
·Vital Signs Devices, a GE Healthcare Company·Product code HGP·October 16, 2012
Bard PEG Safety System ''Guidewire'' Reorder Number: 001928
FDA Recall
Terminated
·Bard Endoscopic Technologies·Product code FMF·August 4, 2003
Bard PEG Safety System ''Guidewire'' Reorder Number: 000930
FDA Recall
Terminated
·Bard Endoscopic Technologies·Product code FMF·August 4, 2003
Bard Ponsky PEG Safety System ''Pull'' Reorder Number: 001925
FDA Recall
Terminated
·Bard Endoscopic Technologies·Product code FMF·August 4, 2003
Bard Ponsky PEG Safety System ''Pull'' Reoder Number: 001927
FDA Recall
Terminated
·Bard Endoscopic Technologies·Product code FMF·August 4, 2003
Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346) Monitor urinary output and bladder temperature in addition to facilitating urine drainage.
FDA Recall
Terminated
·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code EZL·December 2, 2019
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Recall
Terminated
·Degania Medical Devices Pvt. Ltd. Plot No 251 Imt Manesar Gurgaon India·Product code EZL·March 17, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Recall
Terminated
·Degania Medical Devices Pvt. Ltd. Plot No 251 Imt Manesar Gurgaon India·Product code EZL·March 17, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101863MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Recall
Terminated
·Degania Medical Devices Pvt. Ltd. Plot No 251 Imt Manesar Gurgaon India·Product code EZL·March 17, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101863DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Recall
Terminated
·Degania Medical Devices Pvt. Ltd. Plot No 251 Imt Manesar Gurgaon India·Product code EZL·March 17, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Recall
Terminated
·Degania Medical Devices Pvt. Ltd. Plot No 251 Imt Manesar Gurgaon India·Product code EZL·March 17, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Recall
Terminated
·Degania Medical Devices Pvt. Ltd. Plot No 251 Imt Manesar Gurgaon India·Product code EZL·March 17, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101663DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Recall
Terminated
·Degania Medical Devices Pvt. Ltd. Plot No 251 Imt Manesar Gurgaon India·Product code EZL·March 17, 2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101063MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
FDA Recall
Terminated
·Degania Medical Devices Pvt. Ltd. Plot No 251 Imt Manesar Gurgaon India·Product code EZL·March 17, 2020