11 results
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18ms
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Sources: EU EUDAMED, US FDA
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Country: Switzerland
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FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·October 15, 2025
FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·October 15, 2025
Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem-Free Shoulder is designed for long-term implantation into the human shoulder joint as a total shoulder arthroplasty in combination with Zimmer or Biomet s glenoid components, or as a hemi shoulder arthroplasty.
FDA Enforcement
Class II
·Terminated·Zimmer GmbH·October 9, 2019
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 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 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 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
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
Verfora SA
Manufacturer
🇨🇭 Switzerland·1 Importer
TU Bora 2 LK
Device
EU MDR
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Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries
TU Bora 2 LED
Device
EU MDR
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Eu Md Class 2a
·Bien-Air Dental SA·On the market·31 countries