B.Braun Medical, Inc.
Carrollton, TX, US
B.Braun Medical, Inc. appears in FDA device records in Carrollton, TX. FDA records list 149 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 149
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 149FDA records hold 149 510(k) clearances for B.Braun Medical, Inc. between 1993 and 2026. The busiest year on record is 1997, with 18. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 2 |
| 1994 | 1 |
| 1995 | 8 |
| 1996 | 15 |
| 1997 | 18 |
| 1998 | 4 |
| 1999 | 3 |
| 2000 | 2 |
| 2001 | 1 |
| 2002 | 6 |
| 2003 | 7 |
| 2004 | 9 |
| 2005 | 2 |
| 2006 | 4 |
| 2007 | 4 |
| 2008 | 3 |
| 2009 | 7 |
| 2010 | 3 |
| 2011 | 3 |
| 2012 | 3 |
| 2013 | 2 |
| 2014 | 4 |
| 2015 | 4 |
| 2016 | 5 |
| 2017 | 4 |
| 2018 | 5 |
| 2019 | 1 |
| 2020 | 5 |
| 2021 | 2 |
| 2022 | 5 |
| 2023 | 2 |
| 2024 | 3 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253235 | Introcan Safety® Deep Access XL IV Catheter | FOZ | Substantially Equivalent | |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration Sets | FPA | Substantially Equivalent | |
| K240578 | VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System | DTK | Substantially Equivalent | |
| K241845 | Introcan Safety® 2 IV Catheter | FOZ | Substantially Equivalent | |
| K241385 | Omnifix Syringe NRFit | QEH | Substantially Equivalent | |
| K231242 | Perifix FX Catheter; Contiplex FX Catheter | BSO | Substantially Equivalent | |
| K223479 | AQUAbase nX | FIP | Substantially Equivalent | |
| K220756 | Introcan Safety 2 IV Catheter | FOZ | Substantially Equivalent | |
| K220626 | Introcan Safety IV Catheter | FOZ | Substantially Equivalent | |
| K213778 | IV Administration Set | FPA | Substantially Equivalent | |
| K213664 | B. Braun Introcan Safety 2 IV Catheter | FOZ | Substantially Equivalent | |
| K212842 | Microvolume Luer Access Device | FPA | Substantially Equivalent | |
| K213085 | Introcan Safety 3 Closed IV Catheter | FOZ | Substantially Equivalent | |
| K202618 | IV Administration Sets | FPA | Substantially Equivalent | |
| K201469 | Mini Spike Plus 6/8R | LHI | Substantially Equivalent | |
| K192577 | Actreen Hi-Lite Intermittent Urinary Catheters | GBM | Substantially Equivalent | |
| K192676 | Introcan Safety 2 IV Catheter 18-24 gauge | FOZ | Substantially Equivalent | |
| K191658 | IV Sets not made with PVC | FPA | Substantially Equivalent | |
| K193101 | Omnifix Low Dead Space Luer Lock Syringe | FMF | Substantially Equivalent | |
| K182870 | Introcan Safety 3 Closed IV Catheter | FOZ | Substantially Equivalent | |
| K180801 | Actreen Hi-Lite Cath, Actreen Hi-Lite Set | GBM | Substantially Equivalent | |
| K173531 | Lockbox for Perfusor Space PCA Infusion Pump | MRZ | Substantially Equivalent | |
| K173361 | IV Administration Set | FPA | Substantially Equivalent | |
| K172831 | Perfusor® Space Syringe Infusion Pump System | FRN | Substantially Equivalent | |
| K173803 | Omnican fine | FMI | Substantially Equivalent | |
| K171584 | B. Braun Tear-Away Introducer Needle | BSO | Substantially Equivalent | |
| K170595 | IV Administration Sets | FPA | Substantially Equivalent | |
| K170897 | Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site | PTI | Substantially Equivalent | |
| K163430 | Prontosan Wound Gel | FRO | Substantially Equivalent | |
| K161623 | Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL | FRO | Substantially Equivalent | |
| K153297 | Perifix and Contiplex Catheter | BSO | Substantially Equivalent | |
| K153293 | Extension Set | FPA | Substantially Equivalent | |
| K151423 | APEX Compounding System Transfer Set | LHI | Substantially Equivalent | |
| K151772 | Actreen Mini Intermittent Urinary Catheters | GBM | Substantially Equivalent | |
| K150787 | Universal Spike | LHI | Substantially Equivalent | |
| K150800 | Valved Safety Centesis Catheter | GCB | Substantially Equivalent | |
| K143082 | IV Administration Sets with 200(micro)m Blood Filter | FPA | Substantially Equivalent | |
| K142596 | Infusomat Space Volumetric Infusion Pump | FRN | Substantially Equivalent | |
| K140838 | IV ADMINISTRATION SET WITH HAND PUMP | FPA | Substantially Equivalent | |
| K142036 | INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS | FPA | Substantially Equivalent | |
| K133632 | PERICAN ULTRA | BSP | Substantially Equivalent | |
| K140311 | CARESITE LUER ACCESS DEVICE | FPA | Substantially Equivalent | |
| K130857 | PRONTOSAN WOUND GEL X | FRO | Substantially Equivalent | |
| K131842 | STERICAN CANNULA | FMI | Substantially Equivalent | |
| K121846 | CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE | BSP | Substantially Equivalent | |
| K120150 | DUAL SPIKE TRANSFER DEVICE | LHI | Substantially Equivalent | |
| K113059 | CONTIPLEX FX | CAZ | Substantially Equivalent | |
| K112515 | PENCAN SPINAL NEEDLE | BSP | Substantially Equivalent | |
| K112636 | CYTOGUARD(TM) CLOSED LUER CONNECTOR | FPA | Substantially Equivalent | |
| K110744 | PRONTOSAN WOUND IRRIGATION SOLUTION | FRO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KOCAccessories, Blood Circuit, Hemodialysis
- MRZAccessories, Pump, Infusion
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- CAZAnesthesia Conduction Kit
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- KMFBandage, Liquid
- KDHCatheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
- LITCatheter, Angioplasty, Peripheral, Transluminal
- BSOCatheter, Conduction, Anesthetic
- MPBCatheter, Hemodialysis, Non-Implanted
- DQOCatheter, Intravascular, Diagnostic
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- GBXCatheter, Irrigation
- DQYCatheter, Percutaneous
- GBMCatheter, Urethral
- KPEContainer, I.V.
- KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System
- MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
- FRODressing, Wound, Drug
- LDFElectrode, Pacemaker, Temporary
- DTKFilter, Intravascular, Cardiovascular
- DXTInjector And Syringe, Angiographic
- DYBIntroducer, Catheter
- FMJManometer, Spinal-Fluid
- GCBNeedle, Catheter
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- FMINeedle, Hypodermic, Single Lumen
- PTINon-Coring (Huber) Needle
- QEHPiston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular
- FRNPump, Infusion
- MEBPump, Infusion, Elastomeric
- MEAPump, Infusion, Pca
- FPASet, Administration, Intravascular
- LHISet, I.V. Fluid Transfer
- FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve
- BXNStimulator, Nerve, Battery-Powered
- FIPSubsystem, Water Purification
- FMFSyringe, Piston
- IZISystem, X-Ray, Angiographic
- BSSTube, Nasogastric
- DQXWire, Guide, Catheter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain