Thayer Medical Corporation

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
4
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1146-2017Class IIThayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm O.D./I.D. ConnectioSeptember 29, 2016
Z-1927-2012Class IIAirLife¿ MiniSpacer¿ MDI Dispenser Adapter. Dual-Spray MiniSpacer¿ Metered Dose Inhaler (MDI) DispenJune 6, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K233553MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI AdapterJune 18, 2024
K210558LiteAire Basic Dual-Valved, Collapsible MDI Holding ChamberApril 1, 2022
K160109Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding ChamberMay 19, 2017
K111570MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATORSeptember 29, 2011