Medical device manufacturer
B. Braun Medical, Inc.
B. Braun Medical, Inc. holds 151 FDA 510(k) clearances across 44 product codes. Median elapsed review time is 141 days. openFDA lists 508 recall records naming the company. FDA publishes it under 17 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 151
- Product codes
- 44
- Median review
- 141 days
- Recall records
- 508
How does FDA spell B. Braun Medical, Inc.?
FDA publishes this company under 17 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| B BRAUN MEDICAL INC | device/recall | normalised |
| B BRAUN MEDICAL INC | device/enforcement | normalised |
| B Braun Medical Inc | device/recall | normalised |
| B Braun Medical Inc | device/enforcement | normalised |
| B Braun Medical, Inc | device/recall | normalised |
| B Braun Medical, Inc. | device/enforcement | normalised |
| B Braun Medical, Inc. | device/recall | normalised |
| B. BRAUN MEDICAL | device/registrationlisting | normalised |
Showing 8 of 17.
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does B. Braun Medical, Inc. file in?
44 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | 22 | 145 days | |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 12 | 146 days | |
| FRN | Pump, Infusion | 11 | 86 days | |
| DYB | Introducer, Catheter | 9 | 130 days | |
| LHI | Set, I.V. Fluid Transfer | 9 | 139 days | |
| CAZ | Anesthesia Conduction Kit | 7 | 129 days | |
| FRO | Dressing, Wound, Drug | 7 | 150 days | |
| BSO | Catheter, Conduction, Anesthetic | 6 | 90 days | |
| FMF | Syringe, Piston | 6 | 83 days | |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 5 | 114 days | |
| FMI | Needle, Hypodermic, Single Lumen | 5 | 89 days | |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 4 | 141 days | |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 4 | 78 days | |
| DQX | Wire, Guide, Catheter | 3 | 195 days | |
| DXT | Injector And Syringe, Angiographic | 3 | 212 days | |
| GBM | Catheter, Urethral | 3 | 224 days | |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 3 | 67 days | |
| DQO | Catheter, Intravascular, Diagnostic | 2 | 84 days | |
| DTK | Filter, Intravascular, Cardiovascular | 2 | 80 days | |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 2 | 432 days | |
| KPE | Container, I.V. | 2 | 69 days | |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 2 | 94 days | |
| BSS | Tube, Nasogastric | 1 | 405 days | |
| BXN | Stimulator, Nerve, Battery-Powered | 1 | 357 days | |
| DQY | Catheter, Percutaneous | 1 | 77 days |
Showing the 25 they file in most, of 44.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has B. Braun Medical, Inc. had a recall?
openFDA lists 508 recall records naming this company across its whole history, of which 150 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-2276-2026Class IOpen, ClassifiedOFU
A sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huon Co, Ltd. has issued a voluntary recall due to potential quality issues.
Z-2277-2026Class IOpen, ClassifiedOFU
A sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huon Co, Ltd. has issued a voluntary recall due to potential quality issues.
Z-2278-2026Class IOpen, ClassifiedOFU
A sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huon Co, Ltd. has issued a voluntary recall due to potential quality issues.
Z-1798-2026Class IOpen, ClassifiedFJK
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Z-1799-2026Class IOpen, ClassifiedFJK
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Showing the 5 most recently initiated of 508.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has B. Braun Medical, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K253235 | Introcan Safety® Deep Access XL IV Catheter | FOZ | 228 | |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration Sets | FPA | 266 | |
| K240578 | VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System | DTK | 152 | |
| K241845 | Introcan Safety® 2 IV Catheter | FOZ | 30 | |
| K241385 | Omnifix Syringe NRFit | QEH | 59 | |
| K231242 | Perifix FX Catheter; Contiplex FX Catheter | BSO | 137 | |
| K223479 | AQUAbase nX | FIP | 271 | |
| K220756 | Introcan Safety 2 IV Catheter | FOZ | 100 | |
| K220626 | Introcan Safety IV Catheter | FOZ | 71 | |
| K213778 | IV Administration Set | FPA | 90 |
Source: openFDA device/510k · retrieved
Where is B. Braun Medical, Inc. registered?
FDA lists 6 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what B. Braun Medical, Inc. files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.