Data / Medical devices / Germany / B. Braun Melsungen AG
B. Braun Melsungen AG: FDA-registered device maker in MELSUNGEN Hesse, Germany, 55 510(k) clearances
B. Braun Melsungen AG is registered with the FDA (registration 9610825) in MELSUNGEN Hesse, Germany. It lists 26 device types. The FDA files 55 510(k) clearances under its listings, the newest dated May 15, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9610825
- FEI number
- 3002806469
- Address
- Carl-Braun-Str.1, MELSUNGEN Hesse, Germany, 34212
- Owner or operator
- B. BRAUN MELSUNGEN AG (8010484)
- Roles
- Complaint file establishment, Contract sterilizer, Exporter to the US, Manufacturer, Specification developer
- First device listed
- November 29, 2006
- Registered through
- 2026
- Brand names listed
- ACCEL Evacuated Drainage Bottle, Blue Cap, Brachial Plexus Anesthesia Kit, Chemo Dispensing Pin, Continuous Nerve Block Needles, Continuous Nerve Block Sets and Trays (kits), Continuous Nerve Block Sets/Tray, Contiplex C and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 15, 2026 | K253235 | Introcan Safety® Deep Access XL IV Catheter | FOZ | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| July 26, 2024 | K241845 | Introcan Safety® 2 IV Catheter | FOZ | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| July 13, 2024 | K241385 | Omnifix Syringe NRFit | QEH | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| June 23, 2022 | K220756 | Introcan Safety 2 IV Catheter | FOZ | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| May 14, 2022 | K220626 | Introcan Safety IV Catheter | FOZ | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| February 11, 2022 | K213664 | B. Braun Introcan Safety 2 IV Catheter | FOZ | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| October 25, 2021 | K213085 | Introcan Safety 3 Closed IV Catheter | FOZ | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| December 9, 2020 | K201469 | Mini Spike Plus 6/8R | LHI | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| March 12, 2020 | K191910 | SpaceStation MRI | MRZ | Substantially Equivalent | B. Braun Melsugen AG | accessdata.fda.gov |
| March 5, 2020 | K193101 | Omnifix Low Dead Space Luer Lock Syringe | FMF | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| June 12, 2018 | K172831 | Perfusor® Space Syringe Infusion Pump System | FRN | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| June 11, 2018 | K173803 | Omnican fine | FMI | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| May 23, 2017 | K163430 | Prontosan Wound Gel | FRO | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| November 10, 2016 | K161623 | Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL | FRO | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| March 2, 2016 | K152050 | Pencylcap | FMI | Substantially Equivalent | B.Braun Melsungen AG | accessdata.fda.gov |
| June 18, 2015 | K142596 | Infusomat Space Volumetric Infusion Pump | FRN | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| October 8, 2013 | K130857 | PRONTOSAN WOUND GEL X | FRO | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| August 20, 2013 | K131842 | STERICAN CANNULA | FMI | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| November 20, 2012 | K121846 | CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE | BSP | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| December 22, 2011 | K112515 | PENCAN SPINAL NEEDLE | BSP | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| April 16, 2010 | K100241 | CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680 | BSP | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| November 4, 2009 | K092313 | PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM | MEA | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| August 14, 2009 | K090995 | B. BRAUN CONTIPLEX CONTINUOUS NERVE BLOCK SET | CAZ | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| July 1, 2009 | K083689 | INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM | FRN | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| June 29, 2009 | K090884 | PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA. | BSO | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| July 15, 2008 | K081905 | ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP | MEB | Substantially Equivalent | Westmed, Inc. | accessdata.fda.gov |
| June 19, 2008 | K072876 | PRONTOSAN WOUND IRRIGATION SOLUTION | FRO | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| November 8, 2007 | K072247 | STERICAN HYPODERMIC NEEDLES | FMI | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| August 16, 2007 | K071459 | B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES | FMF | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| March 22, 2007 | K070134 | MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098 | BXN | Substantially Equivalent | Stockert GmbH | accessdata.fda.gov |
| November 17, 2006 | K063280 | INJEKT SYRINGE | FMF | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| October 26, 2006 | K062700 | INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM | FRN | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| October 26, 2006 | K062699 | PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM | FRN | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| January 24, 2006 | K052773 | B. BRAUN 0.2 MICRON FILTER | FMF | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| November 17, 2005 | K052313 | STIMUPLEX HNS-12, MODEL 4892098 | BXN | Substantially Equivalent | Stockert GmbH | accessdata.fda.gov |
| September 30, 2004 | K042488 | PERIFIX CATHETER AND CONTIPLEX CATHETER | BSO | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| February 4, 2004 | K033952 | PERIFIX CATHETER CONNECTOR | CAZ | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| October 1, 2003 | K032144 | PERIFIX CATHETER CONNECTOR | CAZ | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| December 4, 2000 | K003029 | INFUSOMAT P | FRN | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| March 23, 1999 | K983794 | CHEMO MINI SPIKE PLUS | LHI | Substantially Equivalent | B. Braun of America, Inc. | accessdata.fda.gov |
| October 17, 1997 | K971233 | SOFT TIP EPIDURAL CATHETER KIT | CAZ | Unknown | B.Braun Medical, Inc. | accessdata.fda.gov |
| April 3, 1997 | K962696 | PERIFIX PEDIATRIC EPIDURAL KIT | CAZ | Unknown | B.Braun Medical, Inc. | accessdata.fda.gov |
| June 21, 1995 | K942391 | BRAUN MANIFOLD | DTL | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| January 26, 1994 | K932569 | PENCIL POINT SPINAL NEEDLE AND TRAY | BSP | Substantially Equivalent | B. Braun of America, Inc. | accessdata.fda.gov |
| December 13, 1993 | K932400 | ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY | BSP | Unknown | B. Braun of America, Inc. | accessdata.fda.gov |
| February 28, 1986 | K860126 | STIMUPLEX, NERVE STIMULATOR | BXN | Substantially Equivalent | Burron Medical Products, Inc. | accessdata.fda.gov |
| February 23, 1984 | K840287 | BRACHIAL PLEXUS ANESTHESIA TRAY | CAZ | Substantially Equivalent | Burron Medical Products, Inc. | accessdata.fda.gov |
| March 8, 1982 | K820454 | THE RED CAP | FMF | Substantially Equivalent | Burron Medical Products, Inc. | accessdata.fda.gov |
| March 8, 1982 | K820453 | THE INT-STOPPER | FPA | Substantially Equivalent | Burron Medical Products, Inc. | accessdata.fda.gov |
| January 25, 1982 | K820047 | SPINOCAN SPINAL NEEDLE | BSP | Substantially Equivalent | Burron Medical Products, Inc. | accessdata.fda.gov |
| December 3, 1981 | K813236 | EPICAN EPIDURAL CANNULA, BEVEL ACCORD | BSP | Substantially Equivalent | Burron Medical Products, Inc. | accessdata.fda.gov |
| December 3, 1981 | K813186 | PERFIX SET FOR EPIDURAL ANESTHESIA W/TUO | CAZ | Substantially Equivalent | Burron Medical Products, Inc. | accessdata.fda.gov |
| December 3, 1981 | K813179 | PERICAN, EPIDURAL CANNULA | BSP | Substantially Equivalent | Burron Medical Products, Inc. | accessdata.fda.gov |
| November 2, 1976 | K760392 | SYRINGES | FMF | Substantially Equivalent | B. Braun Instruments | accessdata.fda.gov |
| November 2, 1976 | K760383 | STOPCOCKS | KGZ | Substantially Equivalent | B. Braun Instruments | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Piston
- All makers of Parenteral Administration Kit
- All makers of Catheter, Conduction, Anesthetic
- All makers of Anesthesia Conduction Kit
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Needle, Conduction, Anesthetic (W/Wo Introducer)
Updated May 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.