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Tracoe Medical GmbH

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K203362TRACOE varioAugust 5, 2021
K172720TRACOE silcosoft Tracheostomy TubeApril 27, 2018
K152778TRACOE Cuff Pressure MonitorDecember 21, 2016
K152865TRACOE smart Cuff ManagerSeptember 27, 2016
K051587TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470October 25, 2005
K043160TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SOFebruary 18, 2005
K961449TRACHEOSTOMY TUBES TRACOE-FLEXSeptember 13, 1996
K781729TRACHEOTOMY TUBESOctober 24, 1978