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Oridion Medical 1987 , Ltd.

FDA 510(k) & PMA Approved Devices — 17 products

Total Devices17
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K200594 Capnostream 35 Portable Respiratory MonitorCCK2020-04-27 View
510(k) K181624 Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling LineCCK2019-03-22 View
510(k) K181467 Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter LineCCK2019-02-08 View
510(k) K121927 MICROSTREAM FILTERLINE ICUCCK2012-11-29 View
510(k) K112368 CAPNOSTREAM20P WITH AI/ODICCK2012-07-19 View
510(k) K093388 SMART CAPNOLINE GUARDIANCCK2010-03-04 View
510(k) K042665 SMART BITEBLOCCCK2004-11-23 View
510(k) K024300 MICROCAP PLUS/NPB-75DQA2003-04-03 View
510(k) K013845 MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINECCK2001-11-29 View
510(k) K011536 MICROSTREAM O2/CO2 ORAL NASAL FILTERLINECCK2001-11-14 View
510(k) K012391 MAC-LINE CO2 NASAL CANNULA SAMPLE LINECCK2001-08-15 View
510(k) K012395 MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINECCK2001-08-15 View
510(k) K012394 ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINECCK2001-08-15 View
510(k) K011668 VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORIMSQ2001-07-09 View
510(k) K011050 MICROSTREAM ORAL NASAL CANNULA FILTERLINECCK2001-05-04 View
510(k) K010024 O2/CO2 NASAL FILTERLINECCK2001-03-14 View
510(k) K002163 MICROSTREAM EXTERNAL BATTERY CHARGERCCK2001-01-11 View
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