FDA Registration
Active
🇺🇸 United States
DAVOL INC., SUB. C.R. BARD, INC.
Reg #: 1213643
·
FEI: 1213643
·
Expires 2026
Products
20
Proprietary Names
33
Establishment Types
2
Classifications
20
Registration Details
- Registration Name
- DAVOL INC., SUB. C.R. BARD, INC.
- Registration Number
- 1213643
- FEI Number
- 1213643
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 100 Crossings Blvd
- City
- Warwick
- State
- RI
- ZIP
- 02886
- Country
- US
Regulatory Submissions
- 510(k) Number
- K061754
- PMA Number
- P150016
Owner / Operator
- Firm Name
- C. R. Bard, Inc.
- Operator Number
- 2212754
- Address
- 1 Becton Drive
- City
- Franklin Lakes
- State
- NJ
- Postal Code
- 07417
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2008-01-09 |
| Surgical Film | OOD | Class 2 | General, Plastic Surgery | No | 2016-11-15 |
| Mesh, Surgical, Absorbable, Abdominal Hernia | OWT | Class 2 | General, Plastic Surgery | No | 2013-03-01 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2011-06-29 |
| Sealant, Polymerizing | NBE | Class 3 | Unknown | No | 2024-02-05 |
| Agent, Absorbable Hemostatic, Collagen Based | LMF | Class 3 | General, Plastic Surgery | No | 2008-01-30 |
| Mesh, Surgical, Deployer | ORQ | Class 2 | General, Plastic Surgery | No | 2017-08-17 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2017-08-17 |
| Mesh, Surgical | FTM | Class 2 | General, Plastic Surgery | No | 2017-02-16 |
| Collagen Surgical Mesh Containing Drugs | PIJ | Class 2 | General, Plastic Surgery | No | 2017-02-16 |
| Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | OXH | Class 2 | General, Plastic Surgery | No | 2017-02-16 |
| Mesh, Surgical, Absorbable, Staple Line Reinforcement | OXC | Class 2 | General, Plastic Surgery | No | 2018-07-13 |
| Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction | OWZ | Class 2 | General, Plastic Surgery | No | 2018-07-13 |
| Agent, Absorbable Hemostatic, Non-Collagen Based | LMG | Class 3 | General, Plastic Surgery | No | 2015-01-14 |
| Splint, Intranasal Septal | LYA | Class 1 | Ear, Nose, Throat | No | 2015-01-14 |
| Polymer, Ear, Nose And Throat, Synthetic, Absorbable | NHB | Class 2 | Ear, Nose, Throat | No | 2015-01-14 |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | Class U | Unknown | No | 2015-01-14 |
| Mesh, Surgical, Collagen, Diaphragmatic Hernia | OWV | Class 2 | General, Plastic Surgery | No | 2014-05-16 |
| Mesh, Surgical, Deployment Balloon | OQL | Class 2 | General, Plastic Surgery | No | 2013-08-09 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2019-06-12 |
Proprietary Names
Composix
ONFLEX
Phasix
Ventrio
Ventralex
3DMax
SorbaFix
PermaFix
Ventralight
OptiFix
GalaFLEX LITE
Tridyne
Bard
PerFix
Avitene
Echo 2
GalaFLEX 3DR
XenMatrix
Ultrafoam
GalaFLEX
Hydro-Surg
ARISTA
FlexiTip
HemaDERM
Kugel
Bard Mesh
BARD
Bard Mesh Pre-Shaped
CapSure
Progel
Echo PS
GalaFLEX 3D
Sepramesh
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility