B. Braun of America, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
19
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K993024CELSITE IMPLANTABLE PORT WITH VALVED CATHETERMarch 13, 2000
K983794CHEMO MINI SPIKE PLUSMarch 23, 1999
K946170COMFORT-Q SUBCUTANEOUS INJECTION SETSNovember 3, 1995
K945850BRAUN DIACAN(R) FISTULA NEEDLESOctober 6, 1995
K942988FILTERED EXTENSION SETSJuly 14, 1995
K945752CELSITE(TM) BRACHIAL VENOUS PORTMay 31, 1995
K945551CELSITE(TM) DUAL VENOUS SYSTEMApril 21, 1995
K943770LOW VOLUME MULTIPORTApril 10, 1995
K950982B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLEApril 4, 1995
K950184B. BRAUN IV START KITSMarch 15, 1995
K943181DISPENSING PIN WITH ONE-WAY VALVESeptember 29, 1994
K940980CHARGED SUPOR(R) FILTER EXTENSION SETJuly 14, 1994
K932569PENCIL POINT SPINAL NEEDLE AND TRAYJanuary 26, 1994
K932400ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAYDecember 13, 1993
K925285DUALTHERM(R) CARDIAC OUTPUT COMPUTERJuly 21, 1993
K925401IV FLUID TRANSFER PINMarch 3, 1993
K915421GUIDEWIRE INTRODUCER SETFebruary 27, 1992
K910503DISCOGRAPHY KITOctober 7, 1991
K911415TRUMPET VALVEJune 3, 1991