FDA Product Code BXN: Stimulator, Nerve, Battery-powered
Leading manufacturers include Life-Tech Intl., Inc., PAJUNK GmbH Medizintechnologie and C.R. Bard, Inc..
63
Total
63
Cleared
124d
Avg days
1976
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Stimulator, Nerve, Battery-powered Devices (Product Code BXN)
63 devices
Cleared
Oct 16, 2022
STIMPOD NMS450 Nerve Stimulator
Xavant Technology (Pty), Ltd.
Anesthesiology
389d
Cleared
Jan 06, 2017
MultiStim ECO
PAJUNK GmbH Medizintechnologie
Anesthesiology
163d
Cleared
Oct 17, 2006
PAJUNK MULTISTIM SENSOR NERVE STIMULATORS
PAJUNK GmbH Medizintechnologie
Anesthesiology
173d
Cleared
Mar 21, 2003
STIMUPLEX-DIG-RC NERVE STIMULATOR
B.Braun Medical, Inc.
Anesthesiology
357d
Cleared
Jan 19, 1996
SENSI-TOUCH EPIDURAL ANESTHESIA FILTER
Sherwood Medical Co.
Anesthesiology
112d
Cleared
Oct 07, 1991
MS-III MINISTIM
Life-Tech Intl., Inc.
Anesthesiology
81d
Cleared
Jun 25, 1991
NEUROMUSCULAR TRANSMISSION MONITOR
Utah Medical Products, Inc.
Anesthesiology
223d
Cleared
Aug 31, 1988
TRACER
Life-Tech Intl., Inc.
Anesthesiology
121d
Cleared
Jul 18, 1988
CONSTANT CURRENT PERIPHERAL NERVE STIM. #NS252
Fisher &Paykel Healthcare , Ltd.
Anesthesiology
34d
Cleared
Mar 11, 1987
MODEL MS-II MINISTIM
Life-Tech Intl., Inc.
Anesthesiology
42d
Cleared
Jun 19, 1986
MODIFIED NEUROMUSCULAR TRANSMISSION MONITOR
Puritan Bennett Corp.
Anesthesiology
15d
Cleared
Feb 28, 1986
STIMUPLEX, NERVE STIMULATOR
Burron Medical Products, Inc.
Anesthesiology
45d
Cleared
Sep 19, 1979
BARD BIOMEDICAL NERVE LOCATOR
C.R. Bard, Inc.
Anesthesiology
60d
Cleared
Jun 13, 1979
NERVE STIMULATOR, DIGITAL PERIPHERAL
C.R. Bard, Inc.
Anesthesiology
7d
Cleared
Feb 06, 1979
STIMULATOR, BATTERY POWERED
Intermedics, Inc.
Anesthesiology
14d
About Product Code BXN - Regulatory Context
510(k) Submission Activity
63 total 510(k) submissions under product code BXN since 1976, with 63 receiving FDA clearance (average review time: 124 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.