Hamilton Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
32 (17 Class I)
510(k) Clearances
45
Inspections
8
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2167-2025Class IBreathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, usedJune 26, 2025
Z-2328-2025Class IHamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a vJune 3, 2025
Z-2020-2024Class IVentilator HAMILTON-C6, PN: 160021May 15, 2024
Z-2528-2023Class IHamilton-MR1, REF: 161010, Intensive Care VentilatorJuly 26, 2023
Z-2525-2023Class IHamilton-C1, REF: 161001, Portable Intensive Care VentilatorJuly 26, 2023
Z-2529-2023Class IHamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilatorJuly 26, 2023
Z-2530-2023Class IHamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilatorJuly 26, 2023
Z-2527-2023Class IHamilton-T1, REF: 161009, Intensive Care and Transport VentilatorJuly 26, 2023
Z-2526-2023Class IHamilton-T1, REF: 161006, Intensive Care and Transport VentilatorJuly 26, 2023
Z-2142-2023Class IHAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support tJune 15, 2023
Z-2139-2023Class IHAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatoryJune 15, 2023
Z-2141-2023Class IHAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults andJune 15, 2023
Z-2140-2023Class IHAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive presJune 15, 2023
Z-1429-2023Class IIHAMILTON-C6, REF: 160021March 14, 2023
Z-0267-2023Class IIHamilton-C6September 22, 2022
Z-1525-2022Class IHAMILTON-C6 Intensive Care Ventilator, REF: 160021June 27, 2022
Z-1385-2022Class IIIHAMILTON-H900 Humidifier, Models: 950001, 950004January 5, 2021
Z-1874-2019Class IHAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators areMarch 25, 2019
Z-1372-2018Class IIHamilton-C3 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and oMarch 12, 2018
Z-1371-2018Class IIHamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and oMarch 12, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K201306HAMILTON-C3February 5, 2021
K201658Hamilton-C6December 11, 2020
K193228Hamilton-G5May 4, 2020
K181216HAMILTON-T1, HAMILTON-C1August 2, 2019
K163283HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010September 20, 2017
K161450HAMILTON-C3April 27, 2017
K153046HAMILTON-MR1September 6, 2016
K152029HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010May 3, 2016
K150893IntelliCuffJanuary 29, 2016
K140939HAMILTON-T1,HAMILTON-C1September 2, 2015
K122438HAMILTON-MR1November 20, 2013
K131774HAMILTON-G5October 9, 2013
K123637HAMILTON-C3December 21, 2012
K121225HAMILTON-C2November 16, 2012
K120574HAMILTON-C1May 30, 2012
K120670HAMILTON-T1April 3, 2012
K112006HAMILTON-TC1February 9, 2012
K103803HAMILTON-G5November 23, 2011
K102775HAMILTON-C2January 21, 2011
K092148HAMILTON-C2March 4, 2010