Medical Device Manufacturer · US , Bethlehem , PA

B. Braun of America, Inc.

19 submissions · 16 cleared · Since 1991
19
Total
16
Cleared
0
Denied

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

B. Braun of America, Inc. has submitted 19 FDA 510(k) premarket notifications since 1991, of which 16 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Port & Catheter, Implanted, Subcutaneous, Intravascular, Set, I.v. Fluid Transfer, Set, Administration, Intravascular, Needle, Conduction, Anesthetic (w/wo Introducer), Needle, Fistula . Use the specialty filter in the sidebar to narrow results.

19 devices
1–19 of 19
CELSITE IMPLANTABLE PORT WITH VALVED CATHETER
K993024 · LJT Port & Catheter,... · General Hospital
Mar 2000 186d
CHEMO MINI SPIKE PLUS
K983794 · LHI Set, I.v. Fluid Transfer · General Hospital
Mar 1999 147d
COMFORT-Q SUBCUTANEOUS INJECTION SETS
K946170 · FOZ Catheter, Intravascular,... · General Hospital
Nov 1995 319d
BRAUN DIACAN(R) FISTULA NEEDLES
K945850 · FIE Needle, Fistula · Gastroenterology & Urology
Oct 1995 310d
FILTERED EXTENSION SETS
K942988 · FPA Set, Administration,... · General Hospital
Jul 1995 389d
CELSITE(TM) BRACHIAL VENOUS PORT
K945752 · LJT Port & Catheter,... · General Hospital
May 1995 189d
CELSITE(TM) DUAL VENOUS SYSTEM
K945551 · LJT Port & Catheter,... · General Hospital
Apr 1995 158d
LOW VOLUME MULTIPORT
K943770 · FPA Set, Administration,... · General Hospital
Apr 1995 251d
B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE
K950982 · FCG Biopsy Needle · Gastroenterology & Urology
Apr 1995 32d
B. BRAUN IV START KITS
K950184 · LRS I.v. Start Kit · General & Plastic Surgery
Mar 1995 57d
DISPENSING PIN WITH ONE-WAY VALVE
K943181 · LHI Set, I.v. Fluid Transfer · General Hospital
Sep 1994 90d
CHARGED SUPOR(R) FILTER EXTENSION SET
K940980 · FPB Filter, Infusion Line · General Hospital
Jul 1994 135d
PENCIL POINT SPINAL NEEDLE AND TRAY
K932569 · BSP Needle, Conduction,... · Anesthesiology
Jan 1994 244d
ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY
K932400 · BSP Needle, Conduction,... · Anesthesiology
Dec 1993 209d
DUALTHERM(R) CARDIAC OUTPUT COMPUTER
K925285 · DQK Computer, Diagnostic,... · Cardiovascular
Jul 1993 274d
IV FLUID TRANSFER PIN
K925401 · LHI Set, I.v. Fluid Transfer · General Hospital
Mar 1993 128d
GUIDEWIRE INTRODUCER SET
K915421 · DYB Introducer, Catheter · Cardiovascular
Feb 1992 87d
DISCOGRAPHY KIT
K910503 · IZG System, X-ray,... · Radiology
Oct 1991 244d
TRUMPET VALVE
K911415 · FMG Stopcock, I.v. Set · General Hospital
Jun 1991 63d
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