B. Braun of America, Inc.
Bethlehem, PA, US
B. Braun of America, Inc. appears in FDA device records in Bethlehem, PA. FDA records list 19 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 19
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 19 510(k) clearances for B. Braun of America, Inc. between 1991 and 2000. The busiest year on record is 1995, with 8. The most recent is 2000, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 2 |
| 1992 | 1 |
| 1993 | 3 |
| 1994 | 3 |
| 1995 | 8 |
| 1999 | 1 |
| 2000 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K993024 | CELSITE IMPLANTABLE PORT WITH VALVED CATHETER | LJT | Substantially Equivalent | |
| K983794 | CHEMO MINI SPIKE PLUS | LHI | Substantially Equivalent | |
| K946170 | COMFORT-Q SUBCUTANEOUS INJECTION SETS | FOZ | Substantially Equivalent | |
| K945850 | BRAUN DIACAN(R) FISTULA NEEDLES | FIE | Substantially Equivalent | |
| K942988 | FILTERED EXTENSION SETS | FPA | Substantially Equivalent | |
| K945752 | CELSITE(TM) BRACHIAL VENOUS PORT | LJT | Substantially Equivalent | |
| K945551 | CELSITE(TM) DUAL VENOUS SYSTEM | LJT | Substantially Equivalent | |
| K943770 | LOW VOLUME MULTIPORT | FPA | Substantially Equivalent | |
| K950982 | B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE | FCG | Substantially Equivalent | |
| K950184 | B. BRAUN IV START KITS | LRS | Unknown | |
| K943181 | DISPENSING PIN WITH ONE-WAY VALVE | LHI | Substantially Equivalent | |
| K940980 | CHARGED SUPOR(R) FILTER EXTENSION SET | FPB | Substantially Equivalent | |
| K932569 | PENCIL POINT SPINAL NEEDLE AND TRAY | BSP | Substantially Equivalent | |
| K932400 | ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY | BSP | Unknown | |
| K925285 | DUALTHERM(R) CARDIAC OUTPUT COMPUTER | DQK | Substantially Equivalent | |
| K925401 | IV FLUID TRANSFER PIN | LHI | Substantially Equivalent | |
| K915421 | GUIDEWIRE INTRODUCER SET | DYB | Substantially Equivalent | |
| K910503 | DISCOGRAPHY KIT | IZG | Unknown | |
| K911415 | TRUMPET VALVE | FMG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- FCGBiopsy Needle
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- DQKComputer, Diagnostic, Programmable
- FPBFilter, Infusion Line
- LRSI.V. Start Kit
- DYBIntroducer, Catheter
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- FIENeedle, Fistula
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular
- FPASet, Administration, Intravascular
- LHISet, I.V. Fluid Transfer
- FMGStopcock, I.V. Set
- IZGSystem, X-Ray, Photofluorographic
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain