15 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Sweden
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Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter
FDA 510(k)
FDA Class 2
·Anesthesiology
PROVOX FREEHANDS HME, MODEL 7710
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251
FDA 510(k)
FDA Class 2
·Anesthesiology
Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.
FDA Enforcement
Class II
·Terminated·Atos Medical AB·May 19, 2021
1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance humification of ventilator-dependent and non-ventilator dependent patients in critical care, home care and anesthesia.
FDA Enforcement
Class II
·Terminated·AB ULAX·October 14, 2020
HME Trach
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·Aktiebolaget Ulax·1 device
HME Small
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·Aktiebolaget Ulax·1 device
HME Large
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·Aktiebolaget Ulax·1 device
HME FLEX
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·Aktiebolaget Ulax·1 device
HME Neo
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·Aktiebolaget Ulax·1 device
HME Trach 6060
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·Aktiebolaget Ulax·1 device
HME Mini Flex
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·Aktiebolaget Ulax·1 device
HME Neo 910
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·Aktiebolaget Ulax·1 device
HME Trach Oxygen 6mm
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·Aktiebolaget Ulax·1 device
Bacterial/Viral Filter w HME
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·Aktiebolaget Ulax·1 device