Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Engineered Medical Systems

FDA 510(k) & PMA Approved Devices — 22 products

Total Devices22
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K023683 MULTI-STRAP FULL FACE MASKBZD2003-12-01 View
510(k) K013728 TRACH VOXJOH2002-07-30 View
510(k) K013122 EMS ELECTROSTATIC FLITER AND HME COMBINATIONCAH2002-04-19 View
510(k) K013123 EMS PULMONARY FUNCTION TESTING FILTERBZG2002-03-14 View
510(k) K013089 EMS HEPA FILTER AND HME COMBINATIONSCAH2002-03-14 View
510(k) K003497 DISPOSABLE PRESSURE MONITORCAP2000-11-30 View
510(k) K000215 SWIVEL ELBOWBZD2000-05-26 View
510(k) K000314 INCENTIVE SPIROMETERBWF2000-04-12 View
510(k) K991955 MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTIONBTM1999-07-06 View
510(k) K991953 MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTIONBTM1999-07-01 View
510(k) K983919 EMS MOUTH TO MASK RESUSCITATORSCBP1999-04-07 View
510(k) K983920 EMS PEEP VALVES- ADJUSTABLEBYE1999-01-22 View
510(k) K972605 EMS NASAL CPAP MASKBZD1998-01-28 View
510(k) K932797 PRESSURE LIMITING ELBOWBTM1993-09-03 View
510(k) K932799 SINGLE USE MANUAL RESUSCITATOR PEEP VALVEBYE1993-09-03 View
510(k) K924671 BAXTER ADULT/PEDI INFANT SINGLE/USE MAN RESUSCITBTM1993-04-21 View
510(k) K930083 EMS BIOPSY INSTRUMENTKNW1993-04-21 View
510(k) K924610 BAXTER ADULT/PEDI/INFANT SINGLE USE MAN RESUSCITBTM1993-04-06 View
510(k) K912203 EMS SINGLE USE MANUAL RESUSCITATORSBTM1991-11-13 View
510(k) K913014 EMS PERCUSSORBYI1991-10-23 View
↑