3 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --- DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC. --- Burn Relief¿ products are self-cooling, non-adhering and are intended to be used on 1st and 2nd degree burns.
FDA Enforcement
Class II
·Terminated·O-Two Medical Technologies, Inc.·July 19, 2017
O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at a rate appropriate for adult patients
FDA Enforcement
Class II
·Terminated·O-Two Medical Technologies, Inc.·July 19, 2017
O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000
FDA Enforcement
Class II
·Terminated·O-Two Medical Technologies, Inc.·August 29, 2018