FDA 510(k) Applications Submitted by B. Braun Medical, Inc.
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K041415 |
05/27/2004 |
EVA TPN CONTAINER |
B. BRAUN MEDICAL, INC. |
K032144 |
07/14/2003 |
PERIFIX CATHETER CONNECTOR |
B. BRAUN MEDICAL, INC. |
K042488 |
09/13/2004 |
PERIFIX CATHETER AND CONTIPLEX CATHETER |
B. BRAUN MEDICAL, INC. |
K033527 |
11/07/2003 |
INTRADYN PEDIATRIC HEMOSTASIS INTRODUCER |
B. BRAUN MEDICAL, INC. |
K033952 |
12/22/2003 |
PERIFIX CATHETER CONNECTOR |
B. BRAUN MEDICAL, INC. |
K030135 |
01/14/2003 |
SAFETY INTRODUCER NEEDLE |
B. BRAUN MEDICAL, INC. |
K020785 |
03/11/2002 |
INTROCAN SAFETY IV CATHETER |
B. BRAUN MEDICAL, INC. |
K022019 |
06/20/2002 |
PERIFIX CATHETER CONNECTOR |
B. BRAUN MEDICAL, INC. |
K090884 |
03/31/2009 |
PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA. |
B. BRAUN MEDICAL, INC. |
K090905 |
04/01/2009 |
ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE |
B. BRAUN MEDICAL, INC. |
K140838 |
04/02/2014 |
IV ADMINISTRATION SET WITH HAND PUMP |
B. BRAUN MEDICAL, INC. |
K112636 |
09/09/2011 |
CYTOGUARD(TM) CLOSED LUER CONNECTOR |
B. BRAUN MEDICAL, INC. |
K960406 |
01/29/1996 |
BRAUN HEMOSTASIS INTRODUCERS |
B. BRAUN MEDICAL, INC. |
K955485 |
12/01/1995 |
BRUN SELECTIVE AND FLUSH ANGIOGRAPHIC CATHETERS |
B. BRAUN MEDICAL, INC. |
K955820 |
12/26/1995 |
BRAUN HEMOSTASIS INTRODUCERS |
B. BRAUN MEDICAL, INC. |
K120150 |
01/18/2012 |
DUAL SPIKE TRANSFER DEVICE |
B. BRAUN MEDICAL, INC. |
K083723 |
12/15/2008 |
A6 LUER ACCESS DEVICE |
B. BRAUN MEDICAL, INC. |
K071459 |
05/25/2007 |
B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES |
B. BRAUN MEDICAL, INC. |
K072247 |
08/13/2007 |
STERICAN HYPODERMIC NEEDLES |
B. BRAUN MEDICAL, INC. |
K052252 |
08/18/2005 |
CONTRAST MEDIA TRANSFER SETS |
B. BRAUN MEDICAL, INC. |
K052393 |
08/31/2005 |
B. BRAUN MODIFIED BICARBONATE DIALYSATE |
B. BRAUN MEDICAL, INC. |
K052773 |
10/03/2005 |
B. BRAUN 0.2 MICRON FILTER |
B. BRAUN MEDICAL, INC. |
K063280 |
10/31/2006 |
INJEKT SYRINGE |
B. BRAUN MEDICAL, INC. |
K970453 |
01/22/1997 |
B. BRAUN MEDICAL INC. TRANSORBENT AND THINSITE BORDER DRESSING |
B. BRAUN MEDICAL, INC. |
K994375 |
12/27/1999 |
HORIZON LIGHT |
B. BRAUN MEDICAL, INC. |
K003029 |
09/28/2000 |
INFUSOMAT P |
B. BRAUN MEDICAL, INC. |
K983005 |
08/28/1998 |
PERFUSOR COMPACT |
B. BRAUN MEDICAL, INC. |
K033575 |
11/12/2003 |
ONE.CLICK NEEDLE |
B. BRAUN MEDICAL, INC. |
K041683 |
06/21/2004 |
B. BRAUN BICARBONATE DIALYSATE |
B. BRAUN MEDICAL, INC. |
K041490 |
06/04/2004 |
IV ADMINISTRATION SETS WITH ULTRABLOCK UV-RESISTANT TUBING |
B. BRAUN MEDICAL, INC. |
K140311 |
02/07/2014 |
CARESITE LUER ACCESS DEVICE |
B. BRAUN MEDICAL, INC. |
K131842 |
06/21/2013 |
STERICAN CANNULA |
B. BRAUN MEDICAL, INC. |
K041222 |
05/10/2004 |
PINNACLE TPN MANAGEMENT SYSTEM TRANSFER SET |
B. BRAUN MEDICAL, INC. |
K011975 |
06/25/2001 |
HORIZON OUTLOOK WITH DOSECOM |
B. BRAUN MEDICAL, INC. |
K022575 |
08/02/2002 |
PERFUSOR COMPACT WITH FM SYSTEM |
B. BRAUN MEDICAL, INC. |
K023189 |
09/24/2002 |
VISTA BASIC WITH FM SYSTEM |
B. BRAUN MEDICAL, INC. |
K083689 |
12/12/2008 |
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM |
B. BRAUN MEDICAL, INC. |
K090141 |
01/21/2009 |
PRONTOSAN ANTIMICROBIAL WOUND GEL |
B. BRAUN MEDICAL, INC. |
K100241 |
01/27/2010 |
CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680 |
B. BRAUN MEDICAL, INC. |
K090995 |
04/07/2009 |
B. BRAUN CONTIPLEX CONTINUOUS NERVE BLOCK SET |
B. BRAUN MEDICAL, INC. |
K112515 |
08/30/2011 |
PENCAN SPINAL NEEDLE |
B. BRAUN MEDICAL, INC. |
K113059 |
10/14/2011 |
CONTIPLEX FX |
B. BRAUN MEDICAL, INC. |
K961107 |
03/20/1996 |
B. BRAUN GUIDEWIRES |
B. BRAUN MEDICAL, INC. |
K971233 |
04/02/1997 |
SOFT TIP EPIDURAL CATHETER KIT |
B. BRAUN MEDICAL, INC. |
K952435 |
05/24/1995 |
CELSITE PEDIATRIC VENOUS SYSTEM |
B. BRAUN MEDICAL, INC. |
K970287 |
01/24/1997 |
LUMBAR PUNCTURE KIT |
B. BRAUN MEDICAL, INC. |
K970359 |
01/31/1997 |
COMBIPROT EMERGENCY ENFUSION DEVICE |
B. BRAUN MEDICAL, INC. |
K960674 |
02/20/1996 |
CONTRAST INJECTION LINES |
B. BRAUN MEDICAL, INC. |
K970736 |
02/28/1997 |
BRAUN PREFILLED SYRINGE |
B. BRAUN MEDICAL, INC. |
K970926 |
03/13/1997 |
DOUBLE LUMEN PICC |
B. BRAUN MEDICAL, INC. |
K961147 |
03/21/1996 |
CLOSED FLUID COLLECTION SYSTEM |
B. BRAUN MEDICAL, INC. |
K971086 |
03/25/1997 |
RADIAL AND FEMORAL ARTERY CATHETER |
B. BRAUN MEDICAL, INC. |
K971085 |
03/25/1997 |
SOFT TIP MULTI-LUMEN CENTRAL VENOUS CATHETER |
B. BRAUN MEDICAL, INC. |
K971259 |
04/04/1997 |
COMBIPORT FLUID LAVAGE DEVICE |
B. BRAUN MEDICAL, INC. |
K961711 |
05/02/1996 |
ASPISAFE GASTRIC TUBE |
B. BRAUN MEDICAL, INC. |
K961745 |
05/06/1996 |
BRAUN PERCUTANEOUS INTRODUCER SET |
B. BRAUN MEDICAL, INC. |
K971924 |
05/23/1997 |
BLUNT SYRINGE CANNULA |
B. BRAUN MEDICAL, INC. |
K971999 |
05/30/1997 |
PERIPHERALLY INSERTED CENTRAL |
B. BRAUN MEDICAL, INC. |
K962141 |
06/03/1996 |
VOLUME CONTROL SYRINGE MODEL VCD-SYR-10 |
B. BRAUN MEDICAL, INC. |
K952572 |
06/05/1995 |
DIALYSIS ADMINISTRATION KITS |
B. BRAUN MEDICAL, INC. |
K952631 |
06/08/1995 |
BRAUN HEMODIALYSIS BLOOD CIRCUITS |
B. BRAUN MEDICAL, INC. |
K962230 |
06/10/1996 |
CELSITE PORT WITH PRECONNECTED CATHETER |
B. BRAUN MEDICAL, INC. |
K952660 |
06/12/1995 |
BRAUN HEMODIALYSIS CATHETER |
B. BRAUN MEDICAL, INC. |
K962696 |
07/11/1996 |
PERIFIX PEDIATRIC EPIDURAL KIT |
B. BRAUN MEDICAL, INC. |
K972703 |
07/18/1997 |
REDYROB-CLOSED WOUND DRAINAGE SYSTEM |
B. BRAUN MEDICAL, INC. |
K982805 |
08/10/1998 |
INTROCAN SAFETY IV CATHETER |
B. BRAUN MEDICAL, INC. |
K973227 |
08/27/1997 |
ASKINA HYDROCOLLOID/THIN |
B. BRAUN MEDICAL, INC. |
K973322 |
09/04/1997 |
DIAPACT CRRT |
B. BRAUN MEDICAL, INC. |
K973371 |
09/08/1997 |
CERTODYN RAECG UNIVERSAL ADAPTER |
B. BRAUN MEDICAL, INC. |
K964352 |
11/01/1996 |
TORQUE DEVICE |
B. BRAUN MEDICAL, INC. |
K974145 |
11/03/1997 |
V3 VALVE |
B. BRAUN MEDICAL, INC. |
K955179 |
11/13/1995 |
CONTRAST MEDIA SET |
B. BRAUN MEDICAL, INC. |
K955398 |
11/24/1995 |
FORMULATION PREPARATION DEVICE |
B. BRAUN MEDICAL, INC. |
K955381 |
11/24/1995 |
B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT |
B. BRAUN MEDICAL, INC. |
K955585 |
12/07/1995 |
V2 INJECTION SITE |
B. BRAUN MEDICAL, INC. |
K964929 |
12/09/1996 |
PERIPHERALLY INSERTED CENTRAL CATHETER |
B. BRAUN MEDICAL, INC. |
K955829 |
12/26/1995 |
SAFPACE SYSTEM |
B. BRAUN MEDICAL, INC. |
K100640 |
03/05/2010 |
20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500 |
B. BRAUN MEDICAL, INC. |
K101882 |
07/06/2010 |
PRONTOSAN ANTIMICROBIAL WOUND GEL |
B. BRAUN MEDICAL, INC. |
K110744 |
03/17/2011 |
PRONTOSAN WOUND IRRIGATION SOLUTION |
B. BRAUN MEDICAL, INC. |
K130857 |
03/28/2013 |
PRONTOSAN WOUND GEL X |
B. BRAUN MEDICAL, INC. |
K121846 |
06/25/2012 |
CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE |
B. BRAUN MEDICAL, INC. |
K163430 |
12/07/2016 |
Prontosan Wound Gel |
B. Braun Medical, Inc. |
K030830 |
03/14/2003 |
B. BRAUN NERVE BLOCK CATHETER |
B. BRAUN MEDICAL, INC. |
K021094 |
04/04/2002 |
INTROCAN SAFETY IV CATHETER |
B. BRAUN MEDICAL, INC. |
K023253 |
09/30/2002 |
PEDIATRIC CENTRAL VENOUS CATHETER KIT |
B. BRAUN MEDICAL, INC. |
K034066 |
12/31/2003 |
B.BRAUN PREMIXED DIALYSATE |
B. BRAUN MEDICAL, INC. |
K063217 |
10/24/2006 |
VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL) |
B. BRAUN MEDICAL, INC. |
K072876 |
10/09/2007 |
PRONTOSAN WOUND IRRIGATION SOLUTION |
B. BRAUN MEDICAL, INC. |
K063282 |
10/31/2006 |
CONTIPLEX STIM CONTINUOUS NERVE BLOCK SET |
B. BRAUN MEDICAL, INC. |
K073396 |
12/03/2007 |
ANTIMICROBIAL ULTRASITE VALUE, ULTRASITE AG |
B. BRAUN MEDICAL, INC. |
K062699 |
09/11/2006 |
PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM |
B. BRAUN MEDICAL, INC. |
K062700 |
09/11/2006 |
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM |
B. BRAUN MEDICAL, INC. |
K021488 |
05/08/2002 |
SURECAN SAFETY HUBER NEEDLE INFUSION SETS |
B. BRAUN MEDICAL, INC. |
K021033 |
03/29/2002 |
STIMUPLEX-DIG-RC NERVE STIMULATOR |
B. BRAUN MEDICAL, INC. |
K031923 |
06/23/2003 |
ULTRASITE VALVE |
B. BRAUN MEDICAL, INC. |
K013610 |
11/05/2001 |
PERIFIX SAFETY EPIDURAL NEEDLES |
B. BRAUN MEDICAL, INC. |
K092313 |
07/30/2009 |
PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM |
B. BRAUN MEDICAL, INC. |
K142036 |
07/28/2014 |
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS |
B. BRAUN MEDICAL, INC. |
K073538 |
12/17/2007 |
DUAL CHAMBER TPN CONTAINER |
B. BRAUN MEDICAL, INC. |
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