Medical Device Manufacturer · US , Bethlehem , PA

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

19 submissions · 16 cleared · Since 1991

Total

Cleared

Denied

B. Braun of America, Inc. has 16 FDA 510(k) cleared medical devices. Based in Bethlehem, US.

Historical record: 16 cleared submissions from 1991 to 2000. Primary specialty: General Hospital.

Browse the FDA 510(k) cleared devices submitted by B. Braun of America, Inc. Filter by specialty or product code using the sidebar.

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

19 devices

1-12 of 19

Cleared Mar 13, 2000

CELSITE IMPLANTABLE PORT WITH VALVED CATHETER

K993024 · LJT

General Hospital · 186d

Cleared Mar 23, 1999

CHEMO MINI SPIKE PLUS

K983794 · LHI

General Hospital · 147d

Cleared Nov 03, 1995

COMFORT-Q SUBCUTANEOUS INJECTION SETS

K946170 · FOZ

General Hospital · 319d

Cleared Oct 06, 1995

BRAUN DIACAN(R) FISTULA NEEDLES

K945850 · FIE

Gastroenterology & Urology · 310d

Cleared Jul 14, 1995

FILTERED EXTENSION SETS

K942988 · FPA

General Hospital · 389d

Cleared May 31, 1995

CELSITE(TM) BRACHIAL VENOUS PORT

K945752 · LJT

General Hospital · 189d

Cleared Apr 21, 1995

CELSITE(TM) DUAL VENOUS SYSTEM

K945551 · LJT

General Hospital · 158d

Cleared Apr 10, 1995

LOW VOLUME MULTIPORT

K943770 · FPA

General Hospital · 251d

Cleared Apr 04, 1995

B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE

K950982 · FCG

Gastroenterology & Urology · 32d

Cleared Mar 15, 1995

B. BRAUN IV START KITS

K950184 · LRS

General & Plastic Surgery · 57d

Cleared Sep 29, 1994

DISPENSING PIN WITH ONE-WAY VALVE

K943181 · LHI

General Hospital · 90d

Cleared Jul 14, 1994

CHARGED SUPOR(R) FILTER EXTENSION SET

K940980 · FPB

General Hospital · 135d

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

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