FDA 510(k) Applications for Medical Device Product Code "BXN"
(Stimulator, Nerve, Battery-Powered)

FDA 510(k) Number Applicant Device Name Decision Date
K843175 ACM SYSTEMS NERVE STIMULATOR Q10 08/20/1984
K811614 ANESTHESIA ASSOC., INC. NERVE STIMULATOR MODEL AA 1050 06/18/1981
K021033 B. BRAUN MEDICAL, INC. STIMUPLEX-DIG-RC NERVE STIMULATOR 03/21/2003
K822137 BEURO TECHNOLOGY DIGISTIM II 07/30/1982
K870619 BIOMETER INTL. A/S ACCELOGRAPH 03/16/1987
K893485 BIOMETER INTL. A/S ACCELOGRAPH NEUROMUSCULAR TRANSMISSION MONITOR 07/28/1989
K892396 BIOMETER INTL. A/S MINI ACCELOGRAPH NEUROMUSCULAR TRANS. MONITOR 10/03/1989
K860187 BIOMETER INTL. A/S MYOGRAPH 2000 - NEURO. TRANS. MONITOR & RECORDING 03/20/1986
K860186 BIOMETER INTL. A/S MYOTEST - NERVE STIMULATOR 03/20/1986
K890746 BIOMETER INTL. A/S MYOTEST DBS NERVE STIMULATOR 07/14/1989
K860126 BURRON MEDICAL PRODUCTS, INC. STIMUPLEX, NERVE STIMULATOR 02/28/1986
K791442 C.R. BARD, INC. BARD BIOMEDICAL NERVE LOCATOR 09/19/1979
K791047 C.R. BARD, INC. NERVE STIMULATOR, DIGITAL PERIPHERAL 06/13/1979
K852962 FISHER & PAYKEL ALLIED PRODUCTS LTD. PERIPHERAL NERVE STIMULATOR MODEL A400 12/09/1985
K883868 FISHER & PAYKEL ELECTRONICS LTD. MODEL NS242 CONSTANT CURRENT PERIPHERAL NERVE STIM 11/28/1988
K882438 FISHER & PAYKEL HEALTHCARE, LTD. CONSTANT CURRENT PERIPHERAL NERVE STIM. #NS252 07/18/1988
K143095 Halyard Health, Inc. MiniStim MS-IVB Peripheral Nerve Stimulator 3/24/2015
K790123 INTERMEDICS, INC. STIMULATOR, BATTERY POWERED 02/06/1979
K111985 INTRONIX TECHNOLOGIES CORP. MYOGUIDE SYSTEM MODEL 8008 12/30/2011
K870338 LIFE-TECH INTL., INC. MODEL MS-II MINISTIM 03/11/1987
K913184 LIFE-TECH INTL., INC. MS-III MINISTIM 10/07/1991
K881842 LIFE-TECH INTL., INC. TRACER 08/31/1988
K771765 MED GENERAL MYO-CHECK 09/30/1977
K853849 MEDAR CORP., INC. MEDAR APM FORCE TRANSDUCER 01/03/1986
K062478 MEDTRONIC A/S CLAVIS 02/08/2007
K904025 MYOTRACK CO. MYOTRACK, MODEL HH 515 03/01/1991
K861935 NATIONAL MEDICAL SALES, INC. MODEL 100 NERVE STIMULATOR 06/13/1986
K822138 NEURO TECHNOLOGY NEUROSTIM II 07/30/1982
K822139 NEURO TECHNOLOGY STIMPEN 09/13/1982
K091155 NEUROMETRIX, INC. ASCEND 09/03/2009
K760614 OUTPUT, INC. PERIPHERAL NERVE STIMULATOR 11/19/1976
K822157 P.B. SERVICES PERIPHERAL NERVE STIMULATOR, MODEL A-200 07/30/1982
K914164 PACE TECH MEDICAL MONITORS, INC. VITALMAX 840 SERIES 04/09/1993
K011308 PAJUNK GMBH MULTISTIM 11/29/2001
K061172 PAJUNK GMBH MEDIZINTECHNOLOGIE PAJUNK MULTISTIM SENSOR NERVE STIMULATORS 10/17/2006
K864829 PROFESSIONAL INSTRUMENTS CO. MODEL NS-3CC NEURO-STIM PERIPHERAL NERVE STIMULAT 01/12/1987
K864830 PROFESSIONAL INSTRUMENTS CO. TEFLON-COATED HYPODERMIC NEEDLES/REGIONAL BLOCK 01/12/1987
K830058 PROTHIA USA, INC. MYOGRAPH 2000 03/07/1983
K823583 PROTHIA USA, INC. MYOTEST NERVE STIMULATOR 12/30/1982
K862149 PURITAN BENNETT CORP. MODIFIED NEUROMUSCULAR TRANSMISSION MONITOR 06/19/1986
K853477 REGIONAL MASTER CORP. NERVE FINDER 01/14/1986
K853476 REGIONAL MASTER CORP. T4 MONITOR STIMULATOR COMPUTER 01/14/1986
K853422 REGIONAL MASTER CORP. THE GRIPPER 01/15/1986
K771237 RULE MEDICAL INSTRUMENTS, INC. NERVE STIMULATORS 08/02/1977
K954525 SHERWOOD MEDICAL CO. SENSI-TOUCH EPIDURAL ANESTHESIA FILTER 01/19/1996
K883807 SINGER MEDICAL PRODUCTS, INC. AXOSTIM 02/09/1989
K896368 SINGER MEDICAL PRODUCTS, INC. MODIFIED AXOSTIM 11/27/1989
K070134 STOCKERT GMBH MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098 03/22/2007
K003983 STOCKERT GMBH STIMUPLEX HNS-11 06/06/2001
K052313 STOCKERT GMBH STIMUPLEX HNS-12, MODEL 4892098 11/17/2005
K061983 STOCKERT GMBH STIMUPLEX PEN 11/21/2006
K121743 SUNMED LLC EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN 03/28/2013
K990323 TE ME NA S.A.R.L. TE ME NA POLYSTIM NERVE STIMILATOR 09/28/2001
K894786 THE HADER CORP. BIO-INDUSTRY STIM POCHE(R) 09/29/1989
K905092 UTAH MEDICAL PRODUCTS, INC. NEUROMUSCULAR TRANSMISSION MONITOR 06/25/1991
K140853 XAVANT TECHNOLOGY (PTY) LTD STIMPOD ST2-3010 NERVE STIMULATOR 11/6/2014
K093591 XAVANT TECHNOLOGY (PTY), LTD. STIMPOD MODEL NMS-400 NERVE STIMULATOR 12/03/2009
K102084 XAVANT TECHNOLOGY (PTY), LTD. STIMPOD NMS450 NERVE STIMULATOR 12/16/2010
K110118 XAVANT TECHNOLOGY (PTY), LTD. STIMTRODE SINGLE USE NERVE STIMULATOR 02/17/2011
K072092 XAVANT TECHNOLOGY (PTY), LTD. XPOD/XMAP NERVE STIMULATOR 11/15/2007


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact