Medical Device Manufacturer · US , Bethlehem , PA

B. Braun of America, Inc. - FDA 510(k) Cleared Devices

19 submissions · 16 cleared · Since 1991

19

Total

16

Cleared

0

Denied

FDA 510(k) Regulatory Record - B. Braun of America, Inc. General Hospital ✕

11 devices

1-11 of 11

Cleared Mar 13, 2000

CELSITE IMPLANTABLE PORT WITH VALVED CATHETER

General Hospital · 186d

Cleared Mar 23, 1999

CHEMO MINI SPIKE PLUS

General Hospital · 147d

Cleared Nov 03, 1995

COMFORT-Q SUBCUTANEOUS INJECTION SETS

General Hospital · 319d

Cleared Jul 14, 1995

FILTERED EXTENSION SETS

General Hospital · 389d

Cleared May 31, 1995

CELSITE(TM) BRACHIAL VENOUS PORT

General Hospital · 189d

Cleared Apr 21, 1995

CELSITE(TM) DUAL VENOUS SYSTEM

General Hospital · 158d

Cleared Apr 10, 1995

LOW VOLUME MULTIPORT

General Hospital · 251d

Cleared Sep 29, 1994

DISPENSING PIN WITH ONE-WAY VALVE

General Hospital · 90d

Cleared Jul 14, 1994

CHARGED SUPOR(R) FILTER EXTENSION SET

General Hospital · 135d

Cleared Mar 03, 1993

IV FLUID TRANSFER PIN

General Hospital · 128d

Cleared Jun 03, 1991

General Hospital · 63d