FDA 510(k) Applications Submitted by Gary J Syring
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K010019 |
01/02/2001 |
STERILE SUBDERMAL NEEDLE ELECTRODES |
NICOLET BIOMEDICAL, INC. |
K040069 |
01/14/2004 |
DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR |
DYMEDIX, INC. |
K040084 |
01/15/2004 |
LIFESTYLE CIRCULATORY ENHANCER |
ADVANCED CIRCULATORY SYSTEMS, INC. |
K020218 |
01/22/2002 |
SNAP EEG MONITOR |
NICOLET BIOMEDICAL, INC. |
K070243 |
01/25/2007 |
SUTRALENE POLYPROPYLENE SUTURES |
VISIONARY MEDICAL SUPPLIES, INC. |
K070272 |
01/29/2007 |
NEUROPORT ELECTRODE |
CYBERKINETICS NEUROTECHNOLOGY SYSTEMS, INC. |
K020468 |
02/12/2002 |
CHIN ELECTRODE |
DYMEDIX, INC. |
K030517 |
02/19/2003 |
BALL RECORDING ELECTRODE/STIMULATION PROBE |
VIASYS HEALTHCARE, INC. |
K060523 |
02/27/2006 |
NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM |
CYBERKINETICS, INC. |
K050521 |
03/01/2005 |
EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S |
INNTEC, INC. |
K960907 |
03/05/1996 |
ORCA |
LUNAR CORP. |
K060579 |
03/06/2006 |
COMFORT/IO IONTOPHORESIS ELECTRODES |
PEPIN MFG., INC. |
K020754 |
03/07/2002 |
NICOLET PIONEER TC8080 |
NICOLET BIOMEDICAL |
K040605 |
03/08/2004 |
DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100 |
DYMEDIX, INC. |
K951094 |
03/09/1995 |
POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM |
OPTICAL SENSORS, INC. |
K961007 |
03/12/1996 |
EXPERT SPINE MORPHOTIETRY REFERENCE |
LUNAR CORP. |
K040654 |
03/12/2004 |
SENSILASE PAD 3000 |
OPTICAL SENSORS, INC. |
K010795 |
03/16/2001 |
CAPNOPROBE SL, MODEL 2000 |
OPTICAL SENSORS, INC. |
K020955 |
03/25/2002 |
NICOLET ELECTROCAUTERY DETECTOR |
NICOLET BIOMEDICAL, INC. |
K070807 |
03/26/2007 |
CUTANEOUS ELECTROTHERAPY AND RECORDING ELECTRODES; TENS ELECTRODES |
PEPIN MFG., INC. |
K001030 |
03/30/2000 |
RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODEL 3000S |
DYMEDIX, INC. |
K090957 |
04/06/2009 |
BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM |
I2S MICRO IMPLANTABLE SYSTEMS, LLC |
K021144 |
04/09/2002 |
SUBDURAL STRIP ELECTRODE |
NICOLET BIOMEDICAL, INC. |
K071202 |
05/01/2007 |
DERMAPORT PERCUTANEOUS VASCULAR ACCESS SYSTEM (PVAS) |
DERMAPORT, INC |
K141146 |
05/05/2014 |
INVISIPORT |
STEALTH THERAPEUTICS, INCORPORATED |
K961944 |
05/20/1996 |
LUNAR REPORT GENERATOR |
LUNAR CORP. |
K031713 |
06/02/2003 |
AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS |
VIASYS HEALTHCARE, INC. |
K011818 |
06/11/2001 |
STERILE EMG ELECTRODES |
NICOLET BIOMEDICAL, INC. |
K041604 |
06/14/2004 |
MACRO-MICRO DEPTH ELECTRODE |
AD-TECH MEDICAL INSTRUMENT CORP. |
K041630 |
06/16/2004 |
ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS |
CARDIOVASCULAR SYSTEMS INCORPORATED |
K021986 |
06/18/2002 |
BRAINET |
NICOLET BIOMEDICAL, INC. |
K051742 |
06/28/2005 |
OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH |
INNTEC, INC. |
K061908 |
07/05/2006 |
NICOLETONE SYSTEM V32 AMPLIFIER |
VIASYS NEUROCARE |
K052059 |
07/29/2005 |
IUI CATHETER, MODEL 9057 |
INNTEC, INC. |
K042130 |
08/06/2004 |
AURA CPAP PATIENT INTERFACE |
AEIOMED INC. |
K042364 |
08/31/2004 |
PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES |
LAMONT MEDICAL INC |
K102592 |
09/09/2010 |
SUTRAZORB |
VISIONARY MEDICAL SUPPLIES, INC. |
K092809 |
09/11/2009 |
HRV ACQUIRE |
WR MEDICAL ELECTRONICS CO. |
K072964 |
10/19/2007 |
NICOLET CORTICAL STIMULATOR |
CARDINAL HEALTH, INC. |
K072993 |
10/23/2007 |
REUSABLE HEADREST WITH NASAL SEAL |
AEIOMED, INC. |
K033401 |
10/24/2003 |
MODIFICATION TO RESQPOD CIRCULATORY ENHANCER |
ADVANCED CIRCULATORY SYSTEMS, INC. |
K042945 |
10/25/2004 |
AURA CPAP SYSTEM |
AEIOMED INC. |
K063560 |
11/28/2006 |
HILGER DUAL-STIM NERVE STIMULATOR |
WR MEDICAL ELECTRONICS CO. |
K053358 |
12/02/2005 |
DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES |
AD-TECH MEDICAL INSTRUMENT CORP. |
K053363 |
12/02/2005 |
DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES |
AD-TECH MEDICAL INSTRUMENT CORP. |
K053648 |
12/30/2005 |
PIONEER TC8080, COMPANION III |
VIASYS NEURO CARE |
K110407 |
02/14/2011 |
INVISIPORT |
STEALTH THERAPEUTICS, INCORPORATED |
K110438 |
02/15/2011 |
SENSILASE PAD-IQ |
VASAMED, INC. |
K011823 |
06/11/2001 |
BIOREHAB SYSTEM |
NICOLET BIOMEDICAL, INC. |
K112094 |
07/22/2011 |
BRAIN BIOPSY NEEDLE |
AD-TECH MEDICAL INSTRUMENT CORP. |
K984579 |
12/23/1998 |
CAPNO PROBE A |
OPTICAL SENSORS, INC. |
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