Company ยท CH
Hamilton Medical AG
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 2021. Name variants (Inc, Corp, punctuation) are merged.
45510(k) clearances (0 in 12 months)
39recalls (2 in 12 months)
35recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 66 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 6 |
| BSK | Cuff, Tracheal Tube, Inflatable | 3 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 3 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 2 |
| BTI | Compressor, Air, Portable | 1 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 |
| GBX | Catheter, Irrigation | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 5, 2021 | K201306 | HAMILTON-C3 Hamilton Medical AG, CH | CBK |
| Dec 11, 2020 | K201658 | Hamilton-C6 Hamilton Medical AG, CH | CBK |
| May 4, 2020 | K193228 | Hamilton-G5 Hamilton Medical AG, CH | CBK |
| Aug 2, 2019 | K181216 | HAMILTON-T1, HAMILTON-C1 Hamilton Medical AG, CH | CBK |
| Sep 20, 2017 | K163283 | HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 Hamilton Medical AG, CH | BTT |
| Apr 27, 2017 | K161450 | HAMILTON-C3 Hamilton Medical AG, CH | CBK |
| Sep 6, 2016 | K153046 | HAMILTON-MR1 Hamilton Medical AG, CH | CBK |
| May 3, 2016 | K152029 | HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 Hamilton Medical AG, CH | BTT |
| Jan 29, 2016 | K150893 | IntelliCuff Hamilton Medical AG, CH | BSK |
| Sep 2, 2015 | K140939 | HAMILTON-T1,HAMILTON-C1 Hamilton Medical AG, CH | CBK |
| Nov 20, 2013 | K122438 | HAMILTON-MR1 Hamilton Medical AG, CH | CBK |
| Oct 9, 2013 | K131774 | HAMILTON-G5 Hamilton Medical AG, CH | CBK |
| Dec 21, 2012 | K123637 | HAMILTON-C3 Hamilton Medical AG, CH | CBK |
| Nov 16, 2012 | K121225 | HAMILTON-C2 Hamilton Medical AG, CH | CBK |
| May 30, 2012 | K120574 | HAMILTON-C1 Hamilton Medical AG, CH | CBK |
| Apr 3, 2012 | K120670 | HAMILTON-T1 Hamilton Medical AG, CH | CBK |
| Feb 9, 2012 | K112006 | HAMILTON-TC1 Hamilton Medical AG, CH | CBK |
| Nov 23, 2011 | K103803 | HAMILTON-G5 Hamilton Medical AG, CH | CBK |
| Jan 21, 2011 | K102775 | HAMILTON-C2 Hamilton Medical AG, CH | CBK |
| Mar 4, 2010 | K092148 | HAMILTON-C2 Hamilton Medical AG, CH | CBK |
| Jun 15, 2009 | K090468 | HAMILTON-C2 Hamilton Medical AG, CH | CBK |
| Sep 25, 2008 | K081521 | MODIFICATION TO HAMILTON-G5 Hamilton Medical AG, CH | CBK |
| Jun 24, 2008 | K080181 | MODIFICATION TO GALILEO GOLD Hamilton Medical AG, CH | CBK |
| Nov 26, 2007 | K070513 | HAMILTON-G5 Hamilton Medical AG, CH | CBK |
| Oct 18, 2007 | K071194 | RAPHAEL COLOR ASV VENTILATOR Hamilton Medical AG, CH | CBK |
| Jul 17, 2006 | K061090 | GALILEO GOLD ASV Hamilton Medical AG, CH | CBK |
| Jan 6, 2006 | K052863 | RAPHAEL COLOR Hamilton Medical AG, CH | CBK |
| Mar 14, 2005 | K041781 | VENTILAIR II MEDICAL AIR COMPRESSOR Hamilton Medical AG | BTI |
| Oct 27, 2004 | K040574 | GALILEO GOLD Hamilton Medical, Inc. | CBK |
| Oct 22, 2003 | K022679 | RAPHAEL Hamilton Medical AG | CBK |
| Sep 9, 2003 | K030563 | ARABELLA NCPAP MASKS Hamilton Medical AG | BZD |
| Jun 23, 2000 | K001686 | GALILEO VENTILATOR Hamilton Medical, Inc. | CBK |
| Sep 14, 1999 | K982910 | HAMILTON MEDICAL GALILEOVENTILATOR Hamilton Medical, Inc. | CBK |
| Mar 16, 1999 | K990293 | ALADDIN II MONITORING OXYGEN/AIR MONITOR Hamilton Medical, Inc. | BZR |
| Apr 24, 1996 | K960359 | ALADDIN MONITORING OXYGEN/AIR MIXER Hamilton Medical, Inc. | BZR |
| Mar 23, 1995 | K945740 | INFANT FLOW SYSTEM Hamilton Medical, Inc. | BZO |
| Dec 20, 1991 | K901448 | VEOLAR VENTILATOR Hamilton Medical, Inc. | CBK |
| Jun 18, 1990 | K900465 | MAX TRANSPORT VENTILATOR Hamilton Medical, Inc. | CBK |
| Sep 26, 1989 | K894426 | LEONARDO INFORMATION SYSTEM Hamilton Medical, Inc. | CBK |
| Sep 22, 1989 | K894316 | AMADEUS VENTILATOR Hamilton Medical, Inc. | CBK |
| Jun 16, 1988 | K881482 | VEOLAR VENTILATOR Hamilton Medical, Inc. | CBK |
| Apr 21, 1988 | K871792 | VEOLAR VENTILATOR Hamilton Medical, Inc. | CBK |
| May 6, 1986 | K861432 | VEOLAR VENTILATOR Hamilton Medical, Inc. | CBK |
| Oct 23, 1985 | K854026 | VEDLAR VENTILATOR (MODIFICATION) Hamilton Medical, Inc. | |
| Jun 27, 1985 | K844809 | CONTINUOUS VENTILATOR Hamilton Medical, Inc. | GBX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2026 | Hamilton Medical AG IntelliCuff, Portable automatic cuff pressure controller
REF: 951001 Open, Classified |
BSK | K150893 |
| Jun 30, 2026 | Hamilton Medical AG Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators. Open, Classified |
BZO | None listed |
| Aug 19, 2025 | Hamilton Medical AG 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 option Open, Classified |
CBK | K201658 |
| Jul 30, 2025 | Hamilton Medical AG 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. Open, Classified |
BZO | None listed |
| Jun 18, 2024 | Hamilton Medical AG Ventilator HAMILTON-C6, PN: 160021 Open, Classified |
CBK | K201658 |
| Sep 20, 2023 | Hamilton Medical, Inc. Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator Open, Classified |
CBK | None listed |
| Sep 20, 2023 | Hamilton Medical, Inc. Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator Open, Classified |
CBK | None listed |
| Sep 20, 2023 | Hamilton Medical, Inc. Hamilton-MR1, REF: 161010, Intensive Care Ventilator Open, Classified |
CBK | K153046 |
| Sep 20, 2023 | Hamilton Medical, Inc. Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator Open, Classified |
CBK | K181216 |
| Sep 20, 2023 | Hamilton Medical, Inc. Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator Open, Classified |
CBK | K181216 |
| Sep 20, 2023 | Hamilton Medical, Inc. Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator Open, Classified |
CBK | K181216 |
| Jul 21, 2023 | Hamilton Medical, Inc. HAMILTON C3 Ventilator REF
160005
Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates Open, Classified |
CBK | K201306 |
| Jul 21, 2023 | Hamilton Medical, Inc. HAMILTON C2 Ventilator
Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates Open, Classified |
CBK | K121225 |
| Jul 21, 2023 | Hamilton Medical, Inc. 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 Open, Classified |
CBK | K181216 |
| Jul 21, 2023 | Hamilton Medical, Inc. HAMILTON C1 Ventilator REF
161001
1610010
Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates Open, Classified |
CBK | K181216 |
| Apr 25, 2023 | Hamilton Medical AG HAMILTON-C6, REF: 160021 Open, Classified |
CBK | K201658 |
| Nov 18, 2022 | Hamilton Medical AG Hamilton-C6 Open, Classified |
CBK | K201658 |
| Jun 27, 2022 | Hamilton Medical AG HAMILTON-C6 Intensive Care Ventilator, REF: 160021 Open, Classified |
CBK | K201658 |
| Jan 5, 2021 | Hamilton Medical AG HAMILTON-H900 Humidifier, Models: 950001, 950004 Completed |
BTT | K163283 |
| Jul 11, 2019 | Hamilton Medical AG 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 ne Terminated |
CBK | K081521 K103803 +1 |
| Mar 12, 2018 | Hamilton Medical AG Hamilton-C3 Ventilator Unit
Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital. Open, Classified |
CBK | K161450 |
| Mar 12, 2018 | Hamilton Medical AG Hamilton-C2 Ventilator Unit
Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital. Open, Classified |
CBK | K121225 |
| Mar 9, 2018 | Hamilton Medical AG 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 configur Terminated |
CBK | K161450 |
| Mar 9, 2018 | Hamilton Medical AG 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 Terminated |
CBK | K140939 |
| Jun 20, 2017 | Hamilton Medical, Inc. 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 Open, Classified |
BSK | K150893 |
| Nov 28, 2016 | Hamilton Medical, Inc. 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 o Terminated |
CBK | K122438 |
| May 9, 2016 | Hamilton Medical, Inc. 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 ped Terminated |
CBK | K070513 K103803 +1 |
| Nov 4, 2015 | Hamilton Medical, Inc. 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 optio Terminated |
CBK | K131774 |
| Jul 10, 2015 | Hamilton Medical, Inc. 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 Terminated |
CBK | K103803 K131774 |
| Jul 2, 2015 | Hamilton Medical, Inc. 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 d Terminated |
BZO | K945740 |
| Jul 2, 2015 | Hamilton Medical, Inc. 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 Terminated |
BZO | K945740 |
| Jul 2, 2015 | Hamilton Medical, Inc. 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 d Terminated |
BZO | K945740 |
| Nov 6, 2013 | Hamilton Medical, Inc. 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 Terminated |
CBK | K121225 |
| Jan 31, 2013 | Hamilton Medical Inc 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 Terminated |
CBK | K120670 |
| Mar 7, 2012 | Hamilton Medical Inc HAMILTON G5 ventilators with software version V2.0x.
Hamilton Medical AG, Switzerland
Imported and distributed by Hamilton Medical, 4990 Energy Way, Reno, NV 89502.
Product Usage:
Hamilton-G5 Ventil Terminated |
CBK | K103803 |
| Apr 8, 2011 | Hamilton Medical Inc Hamilton-G5 Ventilator with software version V2.00x and Neonatal Option or V2.01x and Neonatal software. Hamilton-G5: catalog number 159001;
Neonatal Software catalog number: 159700; Neonatal Option Terminated |
CBK | K081521 |
| Jul 22, 2006 | Hamilton Medical Inc Hamilton brand RAPHAEL Color Ventilator (Software Vesion. 2.2xC, 2.2xCU)Product is distributed by Hamilton Medical, Inc., 4990 Energy Way, Reno, NV 89502 Terminated |
CBK | K022679 K052863 |
| Jul 22, 2006 | Hamilton Medical Inc Hamilton brand RAPHAEL Silver Ventilator (Software Version 2.2xS) Product is distributed by Hamilton Medical, Inc., 4990 Energy Way,
Reno, NV 89502 Terminated |
CBK | K022679 K052863 |
| Jul 22, 2006 | Hamilton Medical Inc Hamilton brand RAPHAEL Ventilator (Software Versio 2.2x), Product is distributed by Hamilton Medical, Inc., 4990 Energy Way,Reno, NV 89502-Serial Numbers 2975 to 5360, Terminated |
CBK | K022679 K052863 |