Data / Medical devices / Agent, Absorbable Hemostatic, Collagen Based
Agent, Absorbable Hemostatic, Collagen Based (LMF): 13 FDA-registered makers in 3 countries
13 establishments in 3 countries are registered with the FDA to make Agent, Absorbable Hemostatic, Collagen Based (product code LMF, Class 3, 21 CFR 878.4490). 7 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 10 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- LMF
- Device class
- 3
- Regulation
- 878.4490
- Medical specialty
- General, Plastic Surgery
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| Poland | 2 |
| Denmark | 1 |
Makers of Agent, Absorbable Hemostatic, Collagen Based
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 |
|---|---|---|---|---|---|---|---|---|
| Davol Inc. | Woburn, MA, United States | Manufacturer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Davol Inc., Sub. C.R. Bard, Inc. | Warwick, RI, United States | Complaint file establishment, Specification developer | 0 | 2 | 1 | 0 | api.fda.gov | |
| Ferrosan Medical Devices A/S | Soeborg Hovedstaden, Denmark | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Integra Lifesciences Corporation | Plainsboro, NJ, United States | Manufacturer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Integra Neurosciences | Anasco, PR, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Integra LifeSciences Corporation | Princeton, NJ, United States | Complaint file establishment, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Pharmacia & Upjohn Company LLC | Kalamazoo, MI, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Baxter Healthcare Corporation | Round Lake, IL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baxter Healthcare Corporation | Hayward, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ferrosan Medical Devices Sp. z o.o. | Szczecin Zachodniopomorskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lyophilization Services Of New England, Inc. | Manchester, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Steripack Medical Poland SP. Z O.O. | Jelcz-Laskowice Dolnoslaskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vascular Solutions LLC | Maple Grove, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.