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Axon Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K090838STIMULUS/DISSECTION INSTRUMENTSJuly 20, 2009
K062996DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBESJanuary 12, 2007
K062198SUNSPOTS PRE-GELLED SURFACE ELECTRODESDecember 19, 2006
K061639ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLNovember 1, 2006
K061113ORTHOMONMay 23, 2006
K050798ECLIPSE NEUROLOGICAL WORKSTATIONAugust 15, 2005
K050194AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODESApril 26, 2005
K032741EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATIONDecember 16, 2003
K022785EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICAL WORKSTATIONOctober 9, 2002
K010697UNIQUE AMBULATORY EEGJune 6, 2001
K002316PHOENIX DIGITAL EEGOctober 26, 2000
K971819EPOCH 2000 NEUROLOGICAL WORKSTATIONNovember 20, 1997
K955257SS102 DUAL CHANNEL SEP STIMULATORFebruary 2, 1996
K900482SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEGJune 20, 1990
K863193SENTINEL 4 EEG ANALYZERDecember 2, 1986