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Sign in to claim this brandDavol Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 160 New Boston St, WOBURN, MA, 01801
- Website
- bd.com
- —
- —
- [email protected]
- Phone
- +1(800)562-0027
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1000120505
- DUNS Number
- 001191048
Catalogue (449)
Page 8 of 9| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Xenmatrix | 1152025 | FDA UDI | Class II | Active |
| Hydro-Surg | 5105010 | FDA UDI | Class II | Unknown |
| Kugel | 0115816 | FDA UDI | Class II | Active |
| Bard | 0112680 | FDA UDI | Class II | Active |
| Dulex | 0175101 | FDA UDI | Class II | Unknown |
| Ultrex | 0067720 | FDA UDI | Class II | Active |
| Xenmatrix | 1150808 | FDA UDI | Class II | Active |
| Xenmatrix | 1160808 | FDA UDI | Class II | Active |
| 3dmax | 0117322 | FDA UDI | Class II | Active |
| Phasix | 1190603 | FDA UDI | Class II | Active |
| Collamend | 1175115 | FDA UDI | Class II | Unknown |
| Phasix | 1212533 | FDA UDI | Class II | Active |
| Arista | SM0002-USA | FDA UDI | Class III | Active |
| Ventralight | 5955790 | FDA UDI | Class II | Active |
| Phasix | 1212025 | FDA UDI | Class II | Active |
| Composix | 0144790 | FDA UDI | Class II | Unknown |
| Capsure | 0113230 | FDA UDI | Class II | Active |
| Ventrio | 0010216 | FDA UDI | Class II | Active |
| Reconix | 0114230 | FDA UDI | Class II | Unknown |
| Phasix | 1190200 | FDA UDI | Class II | Active |
| Avitene | 1010020 | FDA UDI | Class III | Active |
| Xenmatrix | 1161028 | FDA UDI | Class II | Active |
| Bard | 0112720 | FDA UDI | Class II | Active |
| Bard | 0117015 | FDA UDI | Class II | Active |
| Phasix | 1192540 | FDA UDI | Class II | Active |
| PerFix | 0117170 | FDA UDI | Class II | Active |
| PerFix | 0112750 | FDA UDI | Class II | Active |
| Ventralight | 5955610 | FDA UDI | Class II | Active |
| Phasix | 1211525 | FDA UDI | Class II | Active |
| Collamend | 1175112 | FDA UDI | Class II | Unknown |
| Composix | 0134450 | FDA UDI | Class II | Active |
| Xenmatrix | 1161020 | FDA UDI | Class II | Active |
| Hydro-Surg | 0026810 | FDA UDI | Class II | Active |
| Phasix | 1201015 | FDA UDI | Class II | Active |
| Simpulse | 0037740 | FDA UDI | Class II | Unknown |
| Simpulse | 0067640 | FDA UDI | Class II | Active |
| Phasix | 1193535 | FDA UDI | Class II | Active |
| PerFix | 0112950 | FDA UDI | Class II | Active |
| Composix | 0123680 | FDA UDI | Class II | Active |
| Ventrio | 5950020 | FDA UDI | Class II | Active |
| Ventrio | 0010211 | FDA UDI | Class II | Active |
| Ventrio | 5950010 | FDA UDI | Class II | Active |
| Ventrio | 5950090 | FDA UDI | Class II | Active |
| Simpulse VariCare | 0067810 | FDA UDI | Class II | Unknown |
| Sepramesh | 5959812 | FDA UDI | Class II | Active |
| Echo Ps | 5955000 | FDA UDI | Class II | Unknown |
| Ventrio | 0010215 | FDA UDI | Class II | Active |
| Xenmatrix | 1161935 | FDA UDI | Class II | Active |
| Single Use Monopolar Hand Control Pencil | K791137 | FDA 510(k) | Class II | Active |
| Davol/Abamson Silicone Sump Drain | K800081 | FDA 510(k) | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (8)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Mar 25, 2026 | Z-1896-2026 | — | open, classified | Potential for product to contain foreign matter, confirmed to be inspect fragments. |
| Apr 25, 2023 | Z-2242-2023 | — | open, classified | Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection |
| Apr 25, 2023 | Z-2241-2023 | — | open, classified | Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection |
| Apr 25, 2023 | Z-2244-2023 | — | open, classified | Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection |
| Apr 25, 2023 | Z-2243-2023 | — | open, classified | Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection |
| Jun 27, 2022 | Z-1457-2022 | — | open, classified | The device may potentially cause a fire, leading to a safety risk. |
| Jun 7, 2022 | Z-1305-2022 | — | open, classified | The product is not able to provide irrigation. |
| Jun 7, 2022 | Z-1304-2022 | — | open, classified | The product is not able to provide irrigation. |