Data / Medical devices / United States / Davol Inc.
Davol Inc.: FDA-registered device maker in Woburn, MA, United States, 2 510(k) clearances and 3 PMA approvals
Davol Inc. is registered with the FDA (registration 1223089) in Woburn, MA, United States. It lists 7 device types. The FDA files 2 510(k) clearances and 3 PMA approvals under its listings, the newest dated October 22, 2012. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1223089
- FEI number
- 1000120505
- Address
- 160 New Boston St, Woburn, MA, United States, 01801
- Owner or operator
- C. R. Bard, Inc. (2212754)
- Roles
- Manufacturer
- First device listed
- January 30, 2008
- Registered through
- 2027
- Brand names listed
- ARISTA, Avitene, FlexiTip, HemaDERM, Phasix, Ultrafoam
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Absorbable Hemostatic, Collagen Based | LMF | 3 | Manufacturer | accessdata.fda.gov |
| Agent, Absorbable Hemostatic, Non-Collagen Based | LMG | 3 | Manufacturer | accessdata.fda.gov |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | U | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Absorbable, Abdominal Hernia | OWT | 2 | Manufacturer | accessdata.fda.gov |
| Polymer, Ear, Nose And Throat, Synthetic, Absorbable | NHB | 2 | Manufacturer | accessdata.fda.gov |
| Splint, Intranasal Septal | LYA | 1 | Manufacturer | accessdata.fda.gov |
| Surgical Film | OOD | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 22, 2012 | K120728 | PHASIX PLUG AND PATCH | OWT | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| December 17, 2003 | K033666 | HEMADERM | QSY | Substantially Equivalent | Medafor, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 26, 2006 | P050038 | ARISTA AH ABSORBABLE HEMOSTAT | LMG | 40 | July 15, 2026 | accessdata.fda.gov |
| October 24, 1980 | P800002 | AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB | LMF | 33 | September 29, 2026 | accessdata.fda.gov |
| August 26, 1976 | N17600 | AVITENE (MICROFIBRILLAR COLLAGEN HOMOSTAT) | LMF | 43 | July 15, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Agent, Absorbable Hemostatic, Collagen Based
- All makers of Mesh, Surgical, Absorbable, Abdominal Hernia
- All makers of Surgical Film
- All makers of Agent, Absorbable Hemostatic, Non-Collagen Based
- All makers of Splint, Intranasal Septal
- All makers of Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Updated July 15, 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.