Company ยท US
B. Braun of America, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2000. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LHI | Set, I.V. Fluid Transfer | 3 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 3 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 2 |
| FPA | Set, Administration, Intravascular | 2 |
| DQK | Computer, Diagnostic, Programmable | 1 |
| DYB | Introducer, Catheter | 1 |
| FCG | Biopsy Needle | 1 |
| FIE | Needle, Fistula | 1 |
| FMG | Stopcock, I.V. Set | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 |
| FPB | Filter, Infusion Line | 1 |
| IZG | System, X-Ray, Photofluorographic | 1 |
| LRS | I.V. Start Kit | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 13, 2000 | K993024 | CELSITE IMPLANTABLE PORT WITH VALVED CATHETER B. Braun of America, Inc. | LJT |
| Mar 23, 1999 | K983794 | CHEMO MINI SPIKE PLUS B. Braun of America, Inc. | LHI |
| Nov 3, 1995 | K946170 | COMFORT-Q SUBCUTANEOUS INJECTION SETS B. Braun of America, Inc. | FOZ |
| Oct 6, 1995 | K945850 | BRAUN DIACAN(R) FISTULA NEEDLES B. Braun of America, Inc. | FIE |
| Jul 14, 1995 | K942988 | FILTERED EXTENSION SETS B. Braun of America, Inc. | FPA |
| May 31, 1995 | K945752 | CELSITE(TM) BRACHIAL VENOUS PORT B. Braun of America, Inc. | LJT |
| Apr 21, 1995 | K945551 | CELSITE(TM) DUAL VENOUS SYSTEM B. Braun of America, Inc. | LJT |
| Apr 10, 1995 | K943770 | LOW VOLUME MULTIPORT B. Braun of America, Inc. | FPA |
| Apr 4, 1995 | K950982 | B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE B. Braun of America, Inc. | FCG |
| Mar 15, 1995 | K950184 | B. BRAUN IV START KITS B. Braun of America, Inc. | LRS |
| Sep 29, 1994 | K943181 | DISPENSING PIN WITH ONE-WAY VALVE B. Braun of America, Inc. | LHI |
| Jul 14, 1994 | K940980 | CHARGED SUPOR(R) FILTER EXTENSION SET B. Braun of America, Inc. | FPB |
| Jan 26, 1994 | K932569 | PENCIL POINT SPINAL NEEDLE AND TRAY B. Braun of America, Inc. | BSP |
| Dec 13, 1993 | K932400 | ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY B. Braun of America, Inc. | BSP |
| Jul 21, 1993 | K925285 | DUALTHERM(R) CARDIAC OUTPUT COMPUTER B. Braun of America, Inc. | DQK |
| Mar 3, 1993 | K925401 | IV FLUID TRANSFER PIN B. Braun of America, Inc. | LHI |
| Feb 27, 1992 | K915421 | GUIDEWIRE INTRODUCER SET B. Braun of America, Inc. | DYB |
| Oct 7, 1991 | K910503 | DISCOGRAPHY KIT B. Braun of America, Inc. | IZG |
| Jun 3, 1991 | K911415 | TRUMPET VALVE B. Braun of America, Inc. | FMG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||