22 results
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53ms
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Sources: EU EUDAMED, US FDA
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HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and distributed by Hamilton Medical, Inc. Reno, NV 89502 The HAMILTON C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants and neonates depending on its configuration. Intended areas of use: In the intensive care ward or in the recovery room; During transfer of ventilated patients within the hospital.
FDA Enforcement
Class II
·Terminated·Hamilton Medical, Inc.·November 13, 2013
Tempa DOT Single-Use Clinical Thermometer Medical Indicators Made in U.S.A. by Medical Indicators, Inc. 16 Thomas J Rhodes Industrial Drive, Hamilton, NJ 08619 USA Phone 1.888.737.1601 www.medicalindicators.com Per 3M website (this product line was recently bought by Medical Indicators from 3M) and labeling in 806, TempaDOT thermometers are individually wrapped, single-use, disposable clinical thermometers for oral or axillary use.
FDA Enforcement
Class II
·Terminated·Medical Indicators, Inc.·September 18, 2013
Hamilton-MR1, REF: 161010, Intensive Care Ventilator
FDA Enforcement
Class I
·Ongoing·Hamilton Medical, Inc.·September 27, 2023
Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure ventilator support to adults and pediatrics, and optionally infants and neonates. Intended areas of use include: MRI Dept., Intensive, intermediate, emergency and long-term acute care as well as transfer of patients within a hospital.
FDA Enforcement
Class II
·Terminated·Hamilton Medical, Inc.·December 7, 2016
Hamilton Medical Infant Flow Sensor, single use, (1.88m), Part number 155500. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ventilators.
FDA Enforcement
Class II
·Terminated·Hamilton Medical, Inc.·July 8, 2015
Hamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ventilators.
FDA Enforcement
Class II
·Terminated·Hamilton Medical, Inc.·July 8, 2015
HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics
FDA Enforcement
Class I
·Terminated·Hamilton Medical Inc·February 6, 2013
Hamilton Medical Infant Flow Sensor, single use, (3.1m), Part number 260179. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ventilators.
FDA Enforcement
Class II
·Terminated·Hamilton Medical, Inc.·July 8, 2015
Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator
FDA Enforcement
Class I
·Ongoing·Hamilton Medical, Inc.·September 27, 2023
Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator
FDA Enforcement
Class I
·Ongoing·Hamilton Medical, Inc.·September 27, 2023
Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator
FDA Enforcement
Class I
·Ongoing·Hamilton Medical, Inc.·September 27, 2023
Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator
FDA Enforcement
Class I
·Ongoing·Hamilton Medical, Inc.·September 27, 2023
Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator
FDA Enforcement
Class I
·Ongoing·Hamilton Medical, Inc.·September 27, 2023
Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001 and 1590002. Anesthesiology: Hamilton G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infants and neonatal patients. The device is intended for use in the hospital and institutional environment where health care professionals provide patient care.
FDA Enforcement
Class II
·Terminated·Hamilton Medical, Inc.·May 18, 2016
Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy tube during mechanical ventilation. Used in the ventilation of adults, pediatrics, and neonates.
FDA Enforcement
Class II
·Ongoing·Hamilton Medical, Inc.·January 24, 2018
Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 and 159002. Software: 159700.. Intensive care ventilation of adult and pediatric patients and optionally infant and neonatal patients.
FDA Enforcement
Class II
·Terminated·Hamilton Medical, Inc.·August 5, 2015
HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients
FDA Enforcement
Class I
·Terminated·Hamilton Medical, Inc.·November 11, 2015
HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
FDA Enforcement
Class I
·Ongoing·Hamilton Medical, Inc.·August 2, 2023
HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
FDA Enforcement
Class I
·Ongoing·Hamilton Medical, Inc.·August 2, 2023
HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
FDA Enforcement
Class I
·Ongoing·Hamilton Medical, Inc.·August 2, 2023