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Hamilton Medical, Inc.

24 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator recall (Z-2525-2023)Hamilton Medical, Inc.2023-09-20
Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator recall (Z-2526-2023)Hamilton Medical, Inc.2023-09-20
Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator recall (Z-2527-2023)Hamilton Medical, Inc.2023-09-20
Hamilton-MR1, REF: 161010, Intensive Care Ventilator recall (Z-2528-2023)Hamilton Medical, Inc.2023-09-20
Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator recall (Z-2529-2023)Hamilton Medical, Inc.2023-09-20
Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator recall (Z-2530-2023)Hamilton Medical, Inc.2023-09-20
HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventila recall (Z-2139-2023)Hamilton Medical, Inc.2023-07-21
HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive p recall (Z-2140-2023)Hamilton Medical, Inc.2023-07-21
HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adu recall (Z-2141-2023)Hamilton Medical, Inc.2023-07-21
HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory sup recall (Z-2142-2023)Hamilton Medical, Inc.2023-07-21
Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provid recall (Z-0666-2017)Hamilton Medical, Inc.2016-11-28
Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001 and recall (Z-1624-2016)Hamilton Medical, Inc.2016-05-09
HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The recall (Z-0151-2016)Hamilton Medical, Inc.2015-11-04
Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers for G5: 159001 a recall (Z-2057-2015)Hamilton Medical, Inc.2015-07-10
Hamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177. The infant fl recall (Z-1963-2015)Hamilton Medical, Inc.2015-07-02
Hamilton Medical Infant Flow Sensor, single use, (1.88m), Part number 155500. The infant f recall (Z-1964-2015)Hamilton Medical, Inc.2015-07-02
Hamilton Medical Infant Flow Sensor, single use, (3.1m), Part number 260179. The infant fl recall (Z-1965-2015)Hamilton Medical, Inc.2015-07-02
HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; recall (Z-0170-2014)Hamilton Medical, Inc.2013-11-06
HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator recall (Z-0741-2013)Hamilton Medical Inc2013-01-31
HAMILTON G5 ventilators with software version V2.0x. Hamilton Medical AG, Switzerland Impo recall (Z-1185-2012)Hamilton Medical Inc2012-03-07
Hamilton-G5 Ventilator with software version V2.00x and Neonatal Option or V2.01x and Neon recall (Z-1928-2011)Hamilton Medical Inc2011-04-08
Hamilton brand RAPHAEL Ventilator (Software Versio 2.2x), Product is distributed by Hamilt recall (Z-1249-06)Hamilton Medical Inc2006-07-22
Hamilton brand RAPHAEL Silver Ventilator (Software Version 2.2xS) Product is distributed b recall (Z-1250-06)Hamilton Medical Inc2006-07-22
Hamilton brand RAPHAEL Color Ventilator (Software Vesion. 2.2xC, 2.2xCU)Product is distrib recall (Z-1251-06)Hamilton Medical Inc2006-07-22

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Every clearance here is in the API, with alerts when new ones post.