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International Biomedical

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories7
Latest FDA decision2022-10-07
TypeNumberDevice NameCodeDateActions
510(k) K221154 Infant Heel WarmerTM; Heel Snuggler®MPO2022-10-07 View
510(k) K221653 InfaTherm Disposable Infant Warming MattressIMD2022-10-06 View
510(k) K220742 NxtGen Infant Transport IncubatorFPL2022-07-15 View
510(k) K193481 AeroNOx 2.0 Nitric Oxide Titration & Monitoring SystemMRN2020-03-10 View
510(k) K182956 Puffin Lite Infant Resuscitation SystemBTL2019-01-18 View
510(k) K173516 NuBorne Infant WarmerFMT2018-08-17 View
510(k) K160238 Airborne Phototherapy LightLBI2016-06-14 View