Axon Systems, Inc.

Hauppauge, NY, US

Axon Systems, Inc. appears in FDA device records in Hauppauge, NY. FDA records list 15 510(k) clearances between 1986-12-02 and 2009-07-20, no PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 15
PMA records: 0
Recall records: 0
Registered establishments: 0

510(k) clearance history

FDA records hold 15 510(k) clearances for Axon Systems, Inc. between 1986 and 2009. The busiest year on record is 2006, with 3. The most recent is 2009, with 1.

Clearances by year, as a table

510(k) clearance decisions for Axon Systems, Inc., by decision year
Year	Clearances
1986	1
1990	1
1996	1
1997	1
2000	1
2001	1
2002	1
2003	1
2005	2
2006	3
2007	1
2009	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K090838	STIMULUS/DISSECTION INSTRUMENTS	ETN	Substantially Equivalent	2009-07-20
K062996	DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES	GXZ	Substantially Equivalent	2007-01-12
K062198	SUNSPOTS PRE-GELLED SURFACE ELECTRODES	GXY	Substantially Equivalent	2006-12-19
K061639	ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON	GWF	Substantially Equivalent	2006-11-01
K061113	ORTHOMON	GWF	Substantially Equivalent	2006-05-23
K050798	ECLIPSE NEUROLOGICAL WORKSTATION	GWF	Substantially Equivalent	2005-08-15
K050194	AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES	GXZ	Substantially Equivalent	2005-04-26
K032741	EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION	GWF	Substantially Equivalent	2003-12-16
K022785	EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICAL WORKSTATION	GWQ	Substantially Equivalent	2002-10-09
K010697	UNIQUE AMBULATORY EEG	GWQ	Substantially Equivalent	2001-06-06
K002316	PHOENIX DIGITAL EEG	GWQ	Substantially Equivalent	2000-10-26
K971819	EPOCH 2000 NEUROLOGICAL WORKSTATION	GWF	Substantially Equivalent	1997-11-20
K955257	SS102 DUAL CHANNEL SEP STIMULATOR	GWF	Substantially Equivalent	1996-02-02
K900482	SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG	GWF	Substantially Equivalent	1990-06-20
K863193	SENTINEL 4 EEG ANALYZER	GWQ	Substantially Equivalent	1986-12-02

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain