FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K971143 |
AARON MEDICAL INDUSTRIES |
NEURO PULSE II,III |
06/06/1997 |
K152769 |
AD-TECH MEDICAL INSTRUMENT CORPORATION |
FREMAP ELECTRODE |
05/06/2016 |
K200886 |
Allotrope Medical Inc |
StimSite |
11/10/2020 |
K090838 |
AXON SYSTEMS, INC. |
STIMULUS/DISSECTION INSTRUMENTS |
07/20/2009 |
K081742 |
BAXANO, INC. |
BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25 |
09/17/2008 |
K092729 |
BAXANO, INC. |
BAXANO NEURO CHECK DEVICE |
10/02/2009 |
K110696 |
BAXANO, INC. |
NEURO CHECK DEVICE WITH IO-FLEX WIRE |
07/07/2011 |
K103128 |
CADWELL LAB, INC. |
CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE, |
02/23/2011 |
K212355 |
Checkpoint Surgical |
Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large |
08/26/2021 |
K062549 |
EXCEL TECH. LTD. |
XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238 |
10/04/2006 |
K021595 |
GYRUS ENT L.L.C. |
GYRUS ENT NERVE STIMULATOR |
10/24/2002 |
K100992 |
INNOVATIVE SURGICAL SOLUTIONS, LLC ("ISS") |
NEURALMAS |
09/24/2010 |
K152505 |
INOMED MEDIZINTECHNIK GMBH |
C2 NerveMonitor System |
02/01/2016 |
K223254 |
Inomed Medizintechnik GmbH |
C2 Xplore |
01/27/2023 |
K091874 |
INOMED MEDIZINTECHNIK GMBH |
INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656 |
11/18/2009 |
K212164 |
inomed Medizintechnik GmbH |
Mapping Suction Probe |
11/11/2022 |
K122040 |
INVOTEC INTERNATIONAL, INC. |
INVOTEC LARYNGEAL ELECTRODE |
10/31/2013 |
K031510 |
MEDTRONIC XOMED |
NIM-SPINE |
06/18/2003 |
K050162 |
MEDTRONIC XOMED, INC. |
CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE |
03/03/2005 |
K112686 |
MEDTRONIC XOMED, INC. |
NEXT GEN EMG ENDOTRACHEAL TUBE |
06/27/2012 |
K213246 |
Medtronic Xomed, Inc. |
NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long |
03/21/2022 |
K231580 |
Medtronic Xomed, Inc. |
NIMÖ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) |
08/30/2023 |
K063305 |
MEDTRONIC XOMED, INC. |
STIMULATING BUR GUARD |
11/29/2006 |
K014165 |
MEDTRONIC XOMED, INC. |
STIMULUS - DISSECTION INSTRUMENTS |
01/22/2002 |
K031003 |
MEDTRONIC XOMED, INC. |
STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES |
04/11/2003 |
K092292 |
NDI MEDICAL LLC |
CHECKPOINT |
10/28/2009 |
K061365 |
NDI MEDICAL, LLC |
CHECKPOINT WITH ACCUSTIM TECHNOLOGY |
07/12/2006 |
K150005 |
NDI Medical, LLC |
Checkpoint, Checkpoint Head & Neck |
02/19/2015 |
K110712 |
NEUROVISION MEDICAL PRODUCTS, INC. |
DRYTOUCH SUCTION STIMULATOR PROBE |
06/28/2011 |
K110989 |
NEUROVISION MEDICAL PRODUCTS, INC. |
NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE |
11/03/2011 |
K102862 |
NEUROVISION MEDICAL PRODUCTS, INC. |
NEUROVISION SE (NERVEANA) |
12/21/2010 |
K121931 |
NEUROVISION MEDICAL PRODUCTS, INC. |
NONDISPOSABLE STIMULATING INSTRUMENTS |
10/19/2012 |
K110138 |
NEUROVISION MEDICAL PRODUCTS, INC. |
PAIRED HYDROGEL ELECTRODE |
04/08/2011 |
K020955 |
NICOLET BIOMEDICAL, INC. |
NICOLET ELECTROCAUTERY DETECTOR |
04/17/2002 |
K111597 |
NUVASIVE, INC. |
DISPOSABLE STIMULATING ELECTRODE |
10/13/2011 |
K032083 |
NUVASIVE, INC. |
NUVASIVE NEUROVISION JJB SYSTEM |
10/24/2003 |
K040543 |
NUVASIVE, INC. |
NUVASIVE NEUROVISION JJB SYSTEM |
04/01/2004 |
K051718 |
NUVASIVE, INC. |
NUVASIVE NEUROVISION JJB SYSTEM |
09/15/2005 |
K112717 |
NUVASIVE, INC. |
NUVASIVE NVJJB SYSTEM |
04/13/2012 |
K112718 |
NUVASIVE, INC. |
NUVASIVE NVM5 SYSTEM |
03/16/2012 |
K112709 |
NUVASIVE, INCORPORATED |
STIMULATION/DISSECTION INSTRUMENTS |
02/09/2012 |
K230853 |
Nvision Biomedical Technologies, Inc. |
EARP Nerve Cuff Electrode |
10/06/2023 |
K072736 |
RHYTHMLINK INTERNATIONAL, LLC |
RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT |
01/22/2008 |
K112435 |
RHYTHMLINK INTERNATIONAL, LLC |
RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT |
09/22/2011 |
K003745 |
RLN SYSTEMS, INC. |
LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET |
01/16/2001 |
K111671 |
SEASPINE, INC. |
SEASPINE MONOPOLAR PROBE SYSYEM |
12/28/2011 |
K093373 |
SPES MEDICA S.R.L. |
LARYNGEAL SURFACE ELECTRODE |
08/24/2010 |
K133348 |
SPES MEDICA S.R.L. |
STIM PROBE |
11/21/2014 |
K140400 |
STRYKER CORPORATION |
ES2 NEUROMONITORING ACCESSORY INSTRUMENTS |
07/01/2014 |
K121257 |
TECHNOMED EUROPE |
LARYNGEAL ELECTRODE |
08/28/2012 |
K110422 |
TECHNOMED EUROPE |
SURGICAL STIMULATORS |
05/26/2011 |
K991583 |
THE MAGSTIM COMPANY LTD. |
NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR |
05/19/1999 |
K964869 |
THE MAGSTIM COMPANY LTD. |
NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR |
05/14/1997 |
K980148 |
THE MAGSTIM COMPANY LTD. |
NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR |
08/05/1998 |
K083242 |
THE MAGSTIM COMPANY LTD. |
NEUROSIGN AVALANCHE MOTOR NERVE MONITOR |
07/29/2009 |
K071349 |
THE MAGSTIM COMPANY LTD. |
NEUROSIGN LARYNGEAL ELECTRODES |
12/12/2007 |
K053141 |
THE MAGSTIM COMPANY LTD. |
NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800 |
12/14/2005 |
K000507 |
UROMED CORP. |
CAVERMAP SURGICAL AID |
04/21/2000 |
K010213 |
UROMED CORP. |
MODIFICATION TO CAVERMAP SURGICAL AID |
04/20/2001 |
K970971 |
UROMED CORP. |
URO MED NERVE STIMULATOR |
10/27/1997 |
K063560 |
WR MEDICAL ELECTRONICS CO. |
HILGER DUAL-STIM NERVE STIMULATOR |
01/05/2007 |
K112426 |
XIAN FRIENDSHIP MEDICAL ELECTRONICS CO., LTD. |
XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES |
04/02/2012 |
K982595 |
XOMED, INC. |
NIM4 |
09/04/1998 |
K992869 |
XOMED, INC. |
XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE |
10/07/1999 |