Data / Medical devices / Pump, Infusion, Elastomeric
Pump, Infusion, Elastomeric (MEB): 11 FDA-registered makers in 7 countries
11 establishments in 7 countries are registered with the FDA to make Pump, Infusion, Elastomeric (product code MEB, Class 2, 21 CFR 880.5725). 8 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 88 510(k) clearances under this code, the latest on April 24, 2026, and lists 28 recall events (4 Class I). FDA data exported November 2, 2026.
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- Product code
- MEB
- Device class
- 2
- Regulation
- 880.5725
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Thailand | 2 |
| Mexico | 1 |
| South Korea | 1 |
| Germany | 1 |
| Malaysia | 1 |
| Romania | 1 |
Makers of Pump, Infusion, Elastomeric
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Avanos Medical, Inc. | Alpharetta, GA, United States | Complaint file establishment, Specification developer | 5 | March 22, 2019 | 0 | 10 | 1 | api.fda.gov |
| Avent S. de R.L. de C.V. | TIJUANA Baja California, Mexico | Manufacturer, Repackager or relabeler | 5 | March 22, 2019 | 0 | 0 | 0 | api.fda.gov |
| Epic International (Thailand) Co., Ltd. | Amphur Pluakdaeng Rayong, Thailand | Manufacturer | 4 | April 24, 2026 | 0 | 0 | 0 | api.fda.gov |
| Ace Medical | GOYANG-SI Gyeonggi, South Korea | Contract manufacturer, Manufacturer | 1 | May 30, 2006 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Melsungen AG | MELSUNGEN Hesse, Germany | Specification developer | 1 | July 15, 2008 | 0 | 0 | 0 | api.fda.gov |
| Baxter Healthcare Corporation | Round Lake, IL, United States | Complaint file establishment, Specification developer | 1 | June 28, 2001 | 0 | 4 | 0 | api.fda.gov |
| First Medical Source (thailand) Co., Ltd | Sriracha Chon Buri, Thailand | Complaint file establishment, Manufacturer, Specification developer | 1 | November 5, 2024 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 1 | April 30, 2009 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Medical Industries Sdn. Bhd. | PENANG Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baxter Healthcare Corporation | Irvine, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hennig Enterprises Europe S.R.L. | Iasi, Romania | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.