FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K964783 |
ALEXANDER MEDICAL, INC. |
EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT |
02/12/1997 |
K122027 |
ARROW INTERNATIONAL, INC. |
ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER |
08/28/2012 |
K030937 |
ARROW INTERNATIONAL, INC. |
STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK |
04/23/2003 |
K122690 |
ARROW INTERNATIONAL, INC. |
ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE |
12/21/2012 |
K222341 |
Arrow International, LLC |
Arrow 0.2 Micron Flat Filter, GVS |
02/13/2023 |
K001587 |
ARROW INTL., INC. |
19 GA PLASTIC REINFORCED EPIDURAL CATHETER |
07/12/2000 |
K021567 |
ARROW INTL., INC. |
STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000 |
06/19/2002 |
K041158 |
ATRION MEDICAL PRODUCTS, INC. |
ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM |
06/16/2004 |
K014246 |
AVID N.I.T., INC. |
AVID-NIT NERVE STIMULATION NEEDLES |
07/16/2002 |
K090995 |
B. BRAUN MEDICAL, INC. |
B. BRAUN CONTIPLEX CONTINUOUS NERVE BLOCK SET |
08/14/2009 |
K113059 |
B. BRAUN MEDICAL, INC. |
CONTIPLEX FX |
01/24/2012 |
K063282 |
B. BRAUN MEDICAL, INC. |
CONTIPLEX STIM CONTINUOUS NERVE BLOCK SET |
06/20/2007 |
K032144 |
B. BRAUN MEDICAL, INC. |
PERIFIX CATHETER CONNECTOR |
10/01/2003 |
K033952 |
B. BRAUN MEDICAL, INC. |
PERIFIX CATHETER CONNECTOR |
02/04/2004 |
K962696 |
B. BRAUN MEDICAL, INC. |
PERIFIX PEDIATRIC EPIDURAL KIT |
04/03/1997 |
K971233 |
B. BRAUN MEDICAL, INC. |
SOFT TIP EPIDURAL CATHETER KIT |
10/17/1997 |
K012584 |
BD |
MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT |
09/06/2001 |
K954953 |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
B-D DURASAFE COMBINED SPINAL EPIDURAL (CSE) TRAY |
05/20/1996 |
K210983 |
Becton Dickinson and Company |
BD Epilor Syringe |
05/19/2022 |
K080804 |
BUSSE HOSIPITAL DISPOSABLES |
BUSSE PLASTIC LOR SYRINGE |
07/09/2008 |
K063018 |
BUSSE HOSPITAL DISPOSABLES, INC. |
GLASS LOSS OF RESISTANCE SYRINGE |
01/22/2007 |
K051171 |
EPIMED INTERNATIONAL, INC. |
STINGRAY EPIDURAL CATHETER CONNECTOR |
08/26/2005 |
K962821 |
GLOBAL MEDICAL PRODUCTS, LTD. |
EPIDURAL ANESTHESIA KIT AND COMBINED SPINAL EPIDURAL ANESTHESIA KIT |
11/13/1996 |
K994059 |
HDC CORP. |
CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07 |
10/13/2000 |
K022752 |
HDC CORP. |
PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15 |
09/09/2003 |
K954835 |
HOLGRATH MEDICAL TECHNOLOGIES, INC. |
HOLGRATH COMBINED SPINAL EPIDURAL NEEDLE SET |
01/31/1996 |
K113662 |
IMD INC |
FENESTRATED NERVE BLOCK NEEDLE |
04/20/2012 |
K960619 |
INCUTECH, INC. |
MORE-L INJECTOR KIT PLUS |
06/20/1996 |
K951870 |
INCUTECH, INC. |
MORELL INJECTOR |
01/22/1996 |
K201356 |
Jiangsu Caina Medical Co., Ltd |
Plastic LOR Syringe |
02/12/2021 |
K954706 |
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
KENDALL BLUNT TUOHY EPIDURAL NEEDLE |
05/30/1996 |
K001129 |
LIFE-TECH INTL., INC. |
PROLONG, MODELS PL50, PL100, PL150 |
07/06/2000 |
K052954 |
LIFE-TECH, INC. |
CONTISTIM CONTINUOUS STIMULATING CATHETER NERVE BLOCK SET |
02/15/2006 |
K093662 |
LIFE-TECH, INC. |
ECHOBRIGHT |
06/24/2010 |
K111355 |
LIFE-TECH, INC. |
ECHOBRIGHT |
09/16/2011 |
K073187 |
LIFE-TECH, INC. |
PERIPHERAL NERVE BLOCK SUPPORT TRAY |
04/22/2008 |
K102007 |
LIFE-TECH, INC. |
PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC, |
12/22/2010 |
K031128 |
MACOSTA MEDICAL USA, LLC |
B-SMART, MODEL B-01 |
01/15/2004 |
K961075 |
MEDCARE MEDICAL GROUP, INC. |
MEDCARE REGIONAL ANETHESIA KIT |
09/06/1996 |
K991719 |
MEDIMEX HOLFELD GMBH & CO. |
EPISTAR/EPISTAR CSE SPINAL/EPIDURAL ANESTHESIA ADMINISTRATION SETS |
08/18/1999 |
K001940 |
MICOR, INC. |
MICOR ANESTHESIA CONDUCTION KIT |
08/11/2000 |
K052946 |
MPS ACACIA |
MPS ACACIA NERVE BLOCK NEEDLE |
12/08/2005 |
K060563 |
PAJUNK GMBH |
EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV |
06/02/2006 |
K043130 |
PAJUNK GMBH |
MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS |
12/21/2004 |
K013041 |
PAJUNK GMBH |
PLEXOLONG SETS |
06/11/2002 |
K033018 |
PAJUNK GMBH |
STIMULONG PLUS CATHETER SET MODEL, VARIOUS |
05/05/2004 |
K053283 |
PAJUNK GMBH |
UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET |
01/12/2006 |
K202699 |
PAJUNK GmbH Medizintechnologie |
E-Cath STIM acc. Tsui |
12/29/2020 |
K060311 |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
EPILONG KIT FOR ANESTHESIOLOGY |
06/13/2006 |
K082164 |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA OF THE PERIPHERAL PLEXUS: SINGLE SHOT |
10/27/2008 |
K082183 |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA: CSF |
10/28/2008 |
K062902 |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
PAJUNKS EPILONG SET PEDIATRIC |
06/07/2007 |
K062900 |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
PAJUNKS STIMULONG TSUI-METHOD SET |
01/12/2007 |
K113188 |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONG |
03/01/2012 |
K190345 |
Pajunk GmbH Medizintechnologie |
VPC |
05/16/2019 |
K033080 |
PORTEX, INC. |
PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER |
03/10/2004 |
K061737 |
ROBERT BUSSE & CO., INC. |
LOSS OF RESISTANCE SYRINGE |
12/18/2006 |
K983125 |
RUSCH INTL. |
EPIDURAL CATHETER MODELS 1210/1200 |
11/17/1998 |
K962880 |
SHERWOOD MEDICAL CO. |
SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM |
12/09/1996 |
K965017 |
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. |
REGIONAL ANESTHESIA TRAYS |
03/14/1997 |
K110053 |
SMITHS MEDICAL ASD, INC. |
CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT |
09/14/2012 |
K092657 |
SMITHS MEDICAL ASD, INC. |
EPIFUSE CATHETER CONNECTOR, MODEL: 4909E |
11/04/2009 |
K121525 |
SMITHS MEDICAL ASD, INC. |
PERIFUSE CATHETER |
08/02/2012 |
K960100 |
SPINAL SPECIALTIES, INC. |
SPINAL SPECIALTIES NERVE BLOCK TRAY |
04/24/1996 |
K060186 |
TE ME NA SAS |
POLYPLEX STIMULATING CATHETER SYSTEM |
07/18/2006 |
K153652 |
TELEFLEX INC. |
ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set |
06/21/2016 |
K143581 |
Teleflex Medical, Inc. |
Arrow Epidural Catheter Kit |
06/26/2015 |
K161075 |
TELEFLEX MEDICAL, INC. |
Arrow Epidural Catheter Kit |
10/04/2016 |
K121403 |
TELEFLEX, INC. |
CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET |
06/20/2012 |
K103658 |
TELEFLEX, INC. |
FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER |
05/16/2012 |