35 results
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9ms
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Sources: EU EUDAMED, US FDA
CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.
FDA Enforcement
Class I
·Terminated·TERRIFIC CARE LLC·February 13, 2019
Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
FDA Enforcement
Class I
·Ongoing·Pacific Medical Group Inc.·April 28, 2021
Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Grey Electric Heating Pad, PE-MtyBls-HeatPad-12x24-Gry-V2
FDA Enforcement
Class I
·Ongoing·Whele LLC DBA Perch·November 30, 2022
Mighty Bliss Electric Heating Pad, Extra-Large (20 x 24 ) Blue Electric Heating Pad, MB-002
FDA Enforcement
Class I
·Ongoing·Whele LLC DBA Perch·November 30, 2022
Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001
FDA Enforcement
Class I
·Ongoing·Whele LLC DBA Perch·November 30, 2022
TCA Board, 16542A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Enforcement
Class I
·Terminated·Carefusion 211 Inc dba Carefusion·June 22, 2016
AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Enforcement
Class I
·Terminated·Carefusion 211 Inc dba Carefusion·June 22, 2016
AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Enforcement
Class I
·Terminated·Carefusion 211 Inc dba Carefusion·June 22, 2016
Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Enforcement
Class I
·Terminated·Carefusion 211 Inc dba Carefusion·June 22, 2016
Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Enforcement
Class I
·Terminated·Carefusion 211 Inc dba Carefusion·June 22, 2016
Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Enforcement
Class I
·Terminated·Carefusion 211 Inc dba Carefusion·June 22, 2016
AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Enforcement
Class I
·Terminated·Carefusion 211 Inc dba Carefusion·June 22, 2016
AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Enforcement
Class I
·Terminated·Carefusion 211 Inc dba Carefusion·June 22, 2016
AVEA Standard with Compressor ventilator, 17312-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Enforcement
Class I
·Terminated·Carefusion 211 Inc dba Carefusion·June 22, 2016
AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Enforcement
Class I
·Terminated·Carefusion 211 Inc dba Carefusion·June 22, 2016
AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Enforcement
Class I
·Terminated·Carefusion 211 Inc dba Carefusion·June 22, 2016
AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Enforcement
Class I
·Terminated·Carefusion 211 Inc dba Carefusion·June 22, 2016
CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Enforcement
Class I
·Terminated·Carefusion 211 Inc dba Carefusion·June 3, 2015
Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.
FDA Enforcement
Class I
·Terminated·Carefusion 211 Inc dba Carefusion·October 9, 2013
Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842
FDA Enforcement
Class I
·Ongoing·Mercury Enterprises, Inc. dba Mercury Medical·January 22, 2025