Panels › Anesthesiology › Product code BXN · Class 2
Stimulator, Nerve, Battery-Powered
Regulation 868.2775
0510(k)s in 12 months (63 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in BXN
| Company | 510(k)s | Recalls |
|---|---|---|
| Biometer Intl. A/S | 6 | 0 |
| Xavant Technology (Pty), Ltd. | 6 | 0 |
| B.Braun Medical, Inc. | 1 | 4 |
| Stockert GmbH | 4 | 0 |
| Life-Tech Intl., Inc. | 3 | 0 |
| Regional Master Corp. | 3 | 0 |
| C.R. Bard, Inc. | 2 | 0 |
| Neuro Technology | 2 | 0 |
| PAJUNK GmbH Medizintechnologie | 2 | 0 |
| Professional Instruments Co. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 16, 2022 | K213049 | STIMPOD NMS450 Nerve Stimulator Xavant Technology (Pty), Ltd., ZA | BXN |
| Jan 6, 2017 | K162086 | MultiStim ECO PAJUNK GmbH Medizintechnologie, DE | BXN |
| May 13, 2016 | K153045 | SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator Easy Med Instrument Co., Ltd., CN | BXN |
| Mar 24, 2015 | K143095 | MiniStim MS-IVB Peripheral Nerve Stimulator Halyard Health, Inc. | BXN |
| Nov 6, 2014 | K140853 | STIMPOD ST2-3010 NERVE STIMULATOR Xavant Technology (Pty), Ltd., ZA | BXN |
| Mar 28, 2013 | K121743 | EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN Sunmed, LLC, CN | BXN |
| Dec 30, 2011 | K111985 | MYOGUIDE SYSTEM MODEL 8008 Intronix Technologies Corp. | BXN |
| Feb 17, 2011 | K110118 | STIMTRODE SINGLE USE NERVE STIMULATOR Xavant Technology (Pty), Ltd., ZA | BXN |
| Dec 16, 2010 | K102084 | STIMPOD NMS450 NERVE STIMULATOR Xavant Technology (Pty), Ltd., ZA | BXN |
| Dec 3, 2009 | K093591 | STIMPOD MODEL NMS-400 NERVE STIMULATOR Xavant Technology (Pty), Ltd., ZA | BXN |
| Sep 3, 2009 | K091155 | ASCEND Neurometrix, Inc. | BXN |
| Nov 15, 2007 | K072092 | XPOD/XMAP NERVE STIMULATOR Xavant Technology (Pty), Ltd., ZA | BXN |
| Mar 22, 2007 | K070134 | MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098 Stockert GmbH, DE | BXN |
| Feb 8, 2007 | K062478 | CLAVIS Medtronic A/S, DK | BXN |
| Nov 21, 2006 | K061983 | STIMUPLEX PEN Stockert GmbH, DE | BXN |
| Oct 17, 2006 | K061172 | PAJUNK MULTISTIM SENSOR NERVE STIMULATORS PAJUNK GmbH Medizintechnologie | BXN |
| Nov 17, 2005 | K052313 | STIMUPLEX HNS-12, MODEL 4892098 Stockert GmbH, DE | BXN |
| Mar 21, 2003 | K021033 | STIMUPLEX-DIG-RC NERVE STIMULATOR B.Braun Medical, Inc. | BXN |
| Nov 29, 2001 | K011308 | MULTISTIM Pajunk GmbH | BXN |
| Sep 28, 2001 | K990323 | TE ME NA POLYSTIM NERVE STIMILATOR Te ME NA S.A.R.L. | BXN |
| Jun 6, 2001 | K003983 | STIMUPLEX HNS-11 Stockert GmbH, DE | BXN |
| Jan 19, 1996 | K954525 | SENSI-TOUCH EPIDURAL ANESTHESIA FILTER Sherwood Medical Co. | BXN |
| Apr 9, 1993 | K914164 | VITALMAX 840 SERIES Pace Tech Medical Monitors, Inc. | BXN |
| Oct 7, 1991 | K913184 | MS-III MINISTIM Life-Tech Intl., Inc. | BXN |
| Jun 25, 1991 | K905092 | NEUROMUSCULAR TRANSMISSION MONITOR Utah Medical Products, Inc. | BXN |
| Mar 1, 1991 | K904025 | MYOTRACK, MODEL HH 515 Myotrack Co. | BXN |
| Nov 27, 1989 | K896368 | MODIFIED AXOSTIM Singer Medical Products, Inc. | BXN |
| Oct 3, 1989 | K892396 | MINI ACCELOGRAPH NEUROMUSCULAR TRANS. MONITOR Biometer Intl. A/S, DK | BXN |
| Sep 29, 1989 | K894786 | BIO-INDUSTRY STIM POCHE(R) The Hader Corp. | BXN |
| Jul 28, 1989 | K893485 | ACCELOGRAPH NEUROMUSCULAR TRANSMISSION MONITOR Biometer Intl. A/S, DK | BXN |
| Jul 14, 1989 | K890746 | MYOTEST DBS NERVE STIMULATOR Biometer Intl. A/S, DK | BXN |
| Feb 9, 1989 | K883807 | AXOSTIM Singer Medical Products, Inc. | BXN |
| Nov 28, 1988 | K883868 | MODEL NS242 CONSTANT CURRENT PERIPHERAL NERVE STIM Fisher & Paykel Electronics , Ltd., NZ | BXN |
| Aug 31, 1988 | K881842 | TRACER Life-Tech Intl., Inc. | BXN |
| Jul 18, 1988 | K882438 | CONSTANT CURRENT PERIPHERAL NERVE STIM. #NS252 Fisher & Paykel Healthcare, Ltd., NZ | BXN |
| Mar 16, 1987 | K870619 | ACCELOGRAPH Biometer Intl. A/S, DK | BXN |
| Mar 11, 1987 | K870338 | MODEL MS-II MINISTIM Life-Tech Intl., Inc. | BXN |
| Jan 12, 1987 | K864830 | TEFLON-COATED HYPODERMIC NEEDLES/REGIONAL BLOCK Professional Instruments Co. | BXN |
| Jan 12, 1987 | K864829 | MODEL NS-3CC NEURO-STIM PERIPHERAL NERVE STIMULAT Professional Instruments Co. | BXN |
| Jun 19, 1986 | K862149 | MODIFIED NEUROMUSCULAR TRANSMISSION MONITOR Puritan Bennett Corp. | BXN |
| Jun 13, 1986 | K861935 | MODEL 100 NERVE STIMULATOR National Medical Sales, Inc. | BXN |
| Mar 20, 1986 | K860187 | MYOGRAPH 2000 - NEURO. TRANS. MONITOR & RECORDING Biometer Intl. A/S, DK | BXN |
| Mar 20, 1986 | K860186 | MYOTEST - NERVE STIMULATOR Biometer Intl. A/S, DK | BXN |
| Feb 28, 1986 | K860126 | STIMUPLEX, NERVE STIMULATOR Burron Medical Products, Inc. | BXN |
| Jan 15, 1986 | K853422 | THE GRIPPER Regional Master Corp. | BXN |
| Jan 14, 1986 | K853477 | NERVE FINDER Regional Master Corp. | BXN |
| Jan 14, 1986 | K853476 | T4 MONITOR STIMULATOR COMPUTER Regional Master Corp. | BXN |
| Jan 3, 1986 | K853849 | MEDAR APM FORCE TRANSDUCER Medar Corp., Inc. | BXN |
| Dec 9, 1985 | K852962 | PERIPHERAL NERVE STIMULATOR MODEL A400 Fisher & Paykel Allied Products , Ltd., NZ | BXN |
| Aug 20, 1984 | K843175 | NERVE STIMULATOR Q10 Acm Systems | BXN |
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