Medical Device Manufacturer · US , Deer Park , NY

Axon Systems, Inc. - FDA 510(k) Cleared Devices

15 submissions · 15 cleared · Since 1986

Recent clearances: STIMULUS/DISSECTION INSTRUMENTS, DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES, SUNSPOTS PRE-GELLED SURFACE ELECTRODES

15

Total

15

Cleared

0

Denied

FDA 510(k) Regulatory Record - Axon Systems, Inc. Neurology ✕

13 devices

1-13 of 13

Cleared Jan 12, 2007

DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES

Neurology · 102d

Cleared Dec 19, 2006

SUNSPOTS PRE-GELLED SURFACE ELECTRODES

Neurology · 140d

Cleared May 23, 2006

Neurology · 32d

Cleared Aug 15, 2005

ECLIPSE NEUROLOGICAL WORKSTATION

Neurology · 139d

Cleared Apr 26, 2005

AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES

Neurology · 89d

Cleared Dec 16, 2003

EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION

Neurology · 103d

Cleared Oct 09, 2002

EPOCH XP NEUROLOGICAL WORKSTATION

Neurology · 48d

Cleared Jun 06, 2001

UNIQUE AMBULATORY EEG

Neurology · 90d

Cleared Oct 26, 2000

PHOENIX DIGITAL EEG

Neurology · 87d

Cleared Nov 20, 1997

EPOCH 2000 NEUROLOGICAL WORKSTATION

Neurology · 188d

Cleared Feb 02, 1996

SS102 DUAL CHANNEL SEP STIMULATOR

Neurology · 87d

Cleared Jun 20, 1990

SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG

Neurology · 139d

Cleared Dec 02, 1986

SENTINEL 4 EEG ANALYZER

Neurology · 105d