Medical Device Manufacturer · US , Plymouth , MN

B.Braun Medical, Inc.

148 submissions · 145 cleared · Since 1993
148
Total
145
Cleared
0
Denied

B.Braun Medical, Inc. — FDA 510(k) Submissions

B.Braun Medical, Inc. has submitted 148 FDA 510(k) premarket notifications since 1993, of which 145 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Set, Administration, Intravascular, Pump, Infusion, Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days, Set, I.v. Fluid Transfer, Introducer, Catheter . Use the specialty filter in the sidebar to narrow results.

148 devices
1–25 of 148
Infusomat? Space Volumetric Infusion Pump Administration Sets
K243392 · FPA Set, Administration,... · General Hospital
Jul 2025 266d
VenaTech? LP Vena Cava Filter System and VenaTech? Convertible Vena Cava Filter System
K240578 · DTK Filter, Intravascular,... · Cardiovascular
Jul 2024 152d
Introcan Safety? 2 IV Catheter
K241845 · FOZ Catheter, Intravascular,... · General Hospital
Jul 2024 30d
Omnifix Syringe NRFit
K241385 · QEH Piston Syringe With... · General Hospital
Jul 2024 59d
Perifix FX Catheter; Contiplex FX Catheter
K231242 · BSO Catheter, Conduction,... · Anesthesiology
Sep 2023 137d
AQUAbase nX
K223479 · FIP Subsystem, Water... · Gastroenterology & Urology
Aug 2023 271d
Introcan Safety 2 IV Catheter
K220756 · FOZ Catheter, Intravascular,... · General Hospital
Jun 2022 100d
Introcan Safety IV Catheter
K220626 · FOZ Catheter, Intravascular,... · General Hospital
May 2022 71d
IV Administration Set
K213778 · FPA Set, Administration,... · General Hospital
Mar 2022 90d
B. Braun Introcan Safety 2 IV Catheter
K213664 · FOZ Catheter, Intravascular,... · General Hospital
Feb 2022 81d
Microvolume Luer Access Device
K212842 · FPA Set, Administration,... · General Hospital
Jan 2022 133d
Introcan Safety 3 Closed IV Catheter
K213085 · FOZ Catheter, Intravascular,... · General Hospital
Oct 2021 31d
IV Administration Sets
K202618 · FPA Set, Administration,... · General Hospital
Sep 2021 379d
Mini Spike Plus 6/8R
K201469 · LHI Set, I.v. Fluid Transfer · General Hospital
Dec 2020 189d
Actreen Hi-Lite Intermittent Urinary Catheters
K192577 · GBM Catheter, Urethral · Gastroenterology & Urology
May 2020 231d
Introcan Safety 2 IV Catheter 18-24 gauge
K192676 · FOZ Catheter, Intravascular,... · General Hospital
Apr 2020 188d
IV Sets not made with PVC
K191658 · FPA Set, Administration,... · General Hospital
Mar 2020 272d
Omnifix Low Dead Space Luer Lock Syringe
K193101 · FMF Syringe, Piston · General Hospital
Mar 2020 118d
Introcan Safety 3 Closed IV Catheter
K182870 · FOZ Catheter, Intravascular,... · General Hospital
Mar 2019 146d
Actreen Hi-Lite Cath, Actreen Hi-Lite Set
K180801 · GBM Catheter, Urethral · Gastroenterology & Urology
Nov 2018 222d
Lockbox for Perfusor Space PCA Infusion Pump
K173531 · MRZ Accessories, Pump, Infusion · General Hospital
Aug 2018 260d
IV Administration Set
K173361 · FPA Set, Administration,... · General Hospital
Jun 2018 243d
Perfusor? Space Syringe Infusion Pump System
K172831 · FRN Pump, Infusion · General Hospital
Jun 2018 267d
Omnican fine
K173803 · FMI Needle, Hypodermic,... · General Hospital
Jun 2018 178d
B. Braun Tear-Away Introducer Needle
K171584 · BSO Catheter, Conduction,... · Anesthesiology
Dec 2017 205d

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