Hamilton Medical AG
Hamilton Medical AG holds FDA 510(k) medical device clearances, first cleared 2003, most recent 2021, with 14 FDA device recalls on record.
Top product codes for Hamilton Medical AG
FDA recalls by Hamilton Medical AG
10 most recent of 14- Z-2463-2026 — Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
- Z-2625-2026 — IntelliCuff, Portable automatic cuff pressure controller REF: 951001
- Z-2167-2025 — 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.
- Z-2328-2025 — 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.
- Z-2020-2024 — Ventilator HAMILTON-C6, PN: 160021
- Z-1429-2023 — HAMILTON-C6, REF: 160021
- Z-0267-2023 — Hamilton-C6
- Z-1525-2022 — HAMILTON-C6 Intensive Care Ventilator, REF: 160021
- Z-1385-2022 — HAMILTON-H900 Humidifier, Models: 950001, 950004
- Z-1874-2019 — 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Hamilton Medical AG
- K201306 — HAMILTON-C3
- K201658 — Hamilton-C6
- K193228 — Hamilton-G5
- K181216 — HAMILTON-T1, HAMILTON-C1
- K163283 — HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010
- K161450 — HAMILTON-C3
- K153046 — HAMILTON-MR1
- K152029 — HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010
- K150893 — IntelliCuff
- K140939 — HAMILTON-T1,HAMILTON-C1
- K122438 — HAMILTON-MR1
- K131774 — HAMILTON-G5
- K123637 — HAMILTON-C3
- K121225 — HAMILTON-C2
- K120574 — HAMILTON-C1
- K120670 — HAMILTON-T1
- K112006 — HAMILTON-TC1
- K103803 — HAMILTON-G5
- K102775 — HAMILTON-C2
- K092148 — HAMILTON-C2
- K090468 — HAMILTON-C2
- K081521 — MODIFICATION TO HAMILTON-G5
- K080181 — MODIFICATION TO GALILEO GOLD
- K070513 — HAMILTON-G5
- K071194 — RAPHAEL COLOR ASV VENTILATOR
- K061090 — GALILEO GOLD ASV
- K052863 — RAPHAEL COLOR
- K041781 — VENTILAIR II MEDICAL AIR COMPRESSOR
- K022679 — RAPHAEL
- K030563 — ARABELLA NCPAP MASKS
Data sourced from openFDA. This site is unofficial and independent of the FDA.