13 results
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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
Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates.
FDA Enforcement
Class I
·Ongoing·Hamilton Medical AG·August 27, 2025
Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
FDA Enforcement
Class I
·Ongoing·Hamilton Medical AG·August 6, 2025
Ventilator HAMILTON-C6, PN: 160021
FDA Enforcement
Class I
·Ongoing·Hamilton Medical AG·June 26, 2024
Hamilton-C3 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
FDA Enforcement
Class II
·Ongoing·Hamilton Medical AG·April 18, 2018
Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital.
FDA Enforcement
Class II
·Ongoing·Hamilton Medical AG·April 18, 2018
Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is intended to provide positive pressure ventilation support to adults and pediatrics. The device is used in the in the intensive care ward, in the recovery room, and during transfer of ventilated patients within the hospital.
FDA Enforcement
Class II
·Terminated·Hamilton Medical AG·August 22, 2018
Hamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator is intended to provide positive pressure ventilator support to adults, pediatrics, infants and neonates depending on its configuration. The device is used in the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room, and during transfer of ventilated patients within the hospital.
FDA Enforcement
Class II
·Terminated·Hamilton Medical AG·August 22, 2018
HAMILTON-C6 Intensive Care Ventilator, REF: 160021
FDA Enforcement
Class I
·Ongoing·Hamilton Medical AG·August 31, 2022
HAMILTON-H900 Humidifier, Models: 950001, 950004
FDA Enforcement
Class III
·Completed·Hamilton Medical AG·July 20, 2022
Hamilton-C6
FDA Enforcement
Class II
·Ongoing·Hamilton Medical AG·November 30, 2022
HAMILTON-C6, REF: 160021
FDA Enforcement
Class II
·Ongoing·Hamilton Medical AG·May 3, 2023
HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant 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 I
·Terminated·Hamilton Medical AG·July 17, 2019