1,127 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Switzerland
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Linde Gas Schweiz AG
Manufacturer
🇨🇭 Switzerland
Service Gas
Device
EU MDR
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Eu Md Class 1
·Sentec AG·On the market·28 countries
Service Gas
Device
EU MDR
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Eu Md Class 1
·Sentec AG·On the market·28 countries
Calibration Gas
Device
EU MDR
·
Eu Md Class 1
·Sentec AG·On the market·32 countries
Calibration Gas
Device
EU MDR
·
Eu Md Class 1
·Sentec AG·On the market·32 countries
Calibration Gas
Device
EU MDR
·
Eu Md Class 1
·Sentec AG·On the market·32 countries
Service Gas
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Sentec AG·5 devices
SenTec Neonatal Starter Set with and without Service Gas (2 Chargers each) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.
FDA Enforcement
Class II
·Terminated·SenTec AG·August 14, 2019
SenTec Standard Starter Set with and without Service Gas (2 changers each) - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.
FDA Enforcement
Class II
·Terminated·SenTec AG·August 14, 2019
HAMILTON-H900 Humidifier, Models: 950001, 950004
FDA Enforcement
Class III
·Completed·Hamilton Medical AG·July 20, 2022
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
SenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.
FDA Enforcement
Class II
·Terminated·SenTec AG·August 14, 2019
SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.
FDA Enforcement
Class II
·Terminated·SenTec AG·August 14, 2019
SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.]
FDA Enforcement
Class II
·Terminated·SenTec AG·August 14, 2019
INFOMED SA
Manufacturer
🇨🇭 Switzerland·43 Basic UDI-DIs·52 Devices·GMED SAS
EarlySight SA
Manufacturer
🇨🇭 Switzerland
AXIS DENTAL SARL
Manufacturer
🇨🇭 Switzerland·1 Basic UDI-DI·7 Devices·1 Importer
Symbios Orthopédie S.A.
Manufacturer
🇨🇭 Switzerland·1 Importer
X-os S.A.
Manufacturer
🇨🇭 Switzerland·115 Basic UDI-DIs·115 Devices·SGS Belgium NV and SGS Belgium NV
SomnoMed AG
Manufacturer
🇨🇭 Switzerland