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Engineered Medical Systems,Inc

FDA Regulatory Profile

Summary

Total Recalls
1 (1 Class I)
510(k) Clearances
24
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1058-2013Class IRespironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anestheSeptember 12, 2011

Recent 510(k) Clearances

K-NumberDeviceDate
K220533Endoscopy Oxygen MaskNovember 16, 2022
K062104TALKING TRACHApril 20, 2007
K023683MULTI-STRAP FULL FACE MASKDecember 1, 2003
K013728TRACH VOXJuly 30, 2002
K013122EMS ELECTROSTATIC FLITER AND HME COMBINATIONApril 19, 2002
K013089EMS HEPA FILTER AND HME COMBINATIONSMarch 14, 2002
K013123EMS PULMONARY FUNCTION TESTING FILTERMarch 14, 2002
K003497DISPOSABLE PRESSURE MONITORNovember 30, 2000
K000215SWIVEL ELBOWMay 26, 2000
K000314INCENTIVE SPIROMETERApril 12, 2000
K991955MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTIONJuly 6, 1999
K991953MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTIONJuly 1, 1999
K983919EMS MOUTH TO MASK RESUSCITATORSApril 7, 1999
K983920EMS PEEP VALVES- ADJUSTABLEJanuary 22, 1999
K972605EMS NASAL CPAP MASKJanuary 28, 1998
K932797PRESSURE LIMITING ELBOWSeptember 3, 1993
K932799SINGLE USE MANUAL RESUSCITATOR PEEP VALVESeptember 3, 1993
K930083EMS BIOPSY INSTRUMENTApril 21, 1993
K924671BAXTER ADULT/PEDI INFANT SINGLE/USE MAN RESUSCITApril 21, 1993
K924610BAXTER ADULT/PEDI/INFANT SINGLE USE MAN RESUSCITApril 6, 1993