33 results
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11ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
FDA Enforcement
Class I
·Terminated·Nellcor Puritan Bennett Inc. (dba Covidien LP)·December 17, 2014
Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventilator Puritan Bennett" 980 Neonatal Ventilator Puritan Bennett" 980 Universal Ventilator Product Usage: The Puritan Bennett 980 Series Ventilator is designed for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb). It is suitable for service in hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilatory support using medical oxygen and compressed medical air from either an internal air compressor or external air sources to deliver oxygen concentrations of 21% to 100%. Ventilatory support can be delivered invasively or non-invasively, to patients who require the followingtypes of ventilator support: Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube) or non-invasively (via mask or nasal prongs). Assist/ Control, SIMV or Spontaneous modes of ventilation
FDA Enforcement
Class I
·Terminated·COVIDIEN LLC·December 26, 2018
Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part Number: 22660R
FDA Enforcement
Class I
·Terminated·Covidien LLC·October 22, 2014
MediChoice¿ Multifunction Electrode Part Number: MC171 OH
FDA Enforcement
Class I
·Terminated·Covidien LLC·October 22, 2014
Philips HEARTSTART Multifunction Electrode Pads Part Number: M3718A
FDA Enforcement
Class I
·Terminated·Covidien LLC·October 22, 2014
Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Part Number: 40000006
FDA Enforcement
Class I
·Terminated·Covidien LLC·October 22, 2014
Covidien Kendall Adult Multi-Function Defibrillation Electrodes Part Number: 20660
FDA Enforcement
Class I
·Terminated·Covidien LLC·October 22, 2014
Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connected Part Number: 22660PC
FDA Enforcement
Class I
·Terminated·Covidien LLC·October 22, 2014
Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
FDA Enforcement
Class I
·Ongoing·Covidien Llc·July 13, 2022
Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
FDA Enforcement
Class I
·Ongoing·Covidien Llc·July 13, 2022
Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
FDA Enforcement
Class I
·Ongoing·Covidien Llc·July 13, 2022
Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
FDA Enforcement
Class I
·Ongoing·Covidien Llc·July 13, 2022
Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
FDA Enforcement
Class I
·Ongoing·Covidien Llc·July 13, 2022
Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
FDA Enforcement
Class I
·Ongoing·Covidien Llc·July 13, 2022
Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
FDA Enforcement
Class I
·Ongoing·Covidien Llc·July 13, 2022
Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
FDA Enforcement
Class I
·Ongoing·Covidien Llc·July 13, 2022
Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
FDA Enforcement
Class I
·Ongoing·Covidien Llc·July 13, 2022
Puritan Bennett 980 Series Ventilator, 980A1ENNISB
FDA Enforcement
Class I
·Terminated·Covidien Llc·December 15, 2021
Puritan Bennett 980 Series Ventilator, 980S3ENDICU
FDA Enforcement
Class I
·Terminated·Covidien Llc·December 15, 2021
Puritan Bennett 980 Series Ventilator, 980U1ESDIUC
FDA Enforcement
Class I
·Terminated·Covidien Llc·December 15, 2021