Data / Medical devices / United States / Davol Inc., Sub. C.R. Bard, Inc.
Davol Inc., Sub. C.R. Bard, Inc.: FDA-registered device maker in Warwick, RI, United States, 41 510(k) clearances and 5 PMA approvals
Davol Inc., Sub. C.R. Bard, Inc. is registered with the FDA (registration 1213643) in Warwick, RI, United States. It lists 20 device types. The FDA files 41 510(k) clearances and 5 PMA approvals under its listings, the newest dated September 28, 2026. 21 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1213643
- Address
- 100 Crossings Blvd, Warwick, RI, United States, 02886
- Owner or operator
- C. R. Bard, Inc. (2212754)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- February 27, 2007
- Registered through
- 2027
- Brand names listed
- 3DMax, ARISTA, Avitene, BARD, Bard, Bard Mesh, Bard Mesh Pre-Shaped, CapSure and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Absorbable Hemostatic, Collagen Based | LMF | 3 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Agent, Absorbable Hemostatic, Non-Collagen Based | LMG | 3 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Collagen Surgical Mesh Containing Drugs | PIJ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | U | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Mesh, Surgical | FTM | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Mesh, Surgical, Absorbable, Abdominal Hernia | OWT | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Mesh, Surgical, Absorbable, Staple Line Reinforcement | OXC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction | OWZ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Mesh, Surgical, Collagen, Diaphragmatic Hernia | OWV | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | OXH | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Mesh, Surgical, Deployer | ORQ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Mesh, Surgical, Deployment Balloon | OQL | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Mesh, Surgical, Polymeric | FTL | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Polymer, Ear, Nose And Throat, Synthetic, Absorbable | NHB | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Sealant, Polymerizing | NBE | 3 | Complaint file establishment | accessdata.fda.gov |
| Splint, Intranasal Septal | LYA | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Staple, Implantable | GDW | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Surgical Film | OOD | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| September 28, 2026 | K261543 | Phasix ST Parastomal Hernia Mesh | OWT | Substantially Equivalent | Davol, Inc., A Subsidiary of C.R. Bard, Inc. | accessdata.fda.gov |
| June 12, 2025 | K251557 | Bard® Mesh; Bard® Mesh Pre-Shaped | FTL | Substantially Equivalent | Davol, Inc. | accessdata.fda.gov |
| April 9, 2025 | K250098 | Bard Soft Mesh; Bard Soft Mesh Pre-Shaped | FTL | Substantially Equivalent | Davol, Inc. | accessdata.fda.gov |
| February 19, 2025 | K243241 | Phasix ST Umbilical Hernia Patch | OWT | Substantially Equivalent | Davol, Inc., A Subsidiary of C.R. Bard, Inc. | accessdata.fda.gov |
| June 14, 2024 | K241250 | 3DMax Light Mesh | FTL | Substantially Equivalent | Davol Inc., Subsidiary of C. R. Bard, Inc. | accessdata.fda.gov |
| April 9, 2024 | K233999 | GalaFLEX LITE Scaffold | OOD | Substantially Equivalent | Tepha, Inc. | accessdata.fda.gov |
| November 1, 2023 | K233402 | Bard 3DMax Mesh | FTL | Substantially Equivalent | Davol Inc., Subsidiary of C. R. Bard, Inc. | accessdata.fda.gov |
| July 17, 2020 | K200818 | 3DMax MID Anatomical Mesh | FTL | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| July 16, 2019 | K191287 | OptiFix AT Absorbable Fixation System with Articulating Technology 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology 15 Fasteners | GDW | Substantially Equivalent | Davol Inc., Subsidiary of C.R. Bard | accessdata.fda.gov |
| June 12, 2019 | K190185 | Phasix ST Mesh with Open Positioning System | OWT | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| December 14, 2018 | K182008 | Phasix ST Mesh with Echo 2 Positioning System | FTL | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| April 25, 2018 | K173143 | Phasix ST Mesh | OWT | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| May 1, 2017 | K170294 | VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4x 6) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6x8) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 25cm (6x10) Oval | FTL | Substantially Equivalent | C. R. Bard | accessdata.fda.gov |
| April 11, 2017 | K163698 | OptiFix Open Absorbable Fixation System - 20 absorbable fasteners | GDW | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| February 23, 2017 | K162922 | GalaFORM 3D | OOD | Substantially Equivalent | Tepha, Inc. | accessdata.fda.gov |
| December 23, 2016 | K162193 | XenMatrix AB Surgical Graft | PIJ | Substantially Equivalent | C. R. Bard | accessdata.fda.gov |
| September 29, 2016 | K161424 | Phasix Mesh | OOD | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| August 23, 2016 | K161092 | GalaSHAPE 3D | OOD | Substantially Equivalent | Tepha, Inc. | accessdata.fda.gov |
| May 31, 2016 | K160900 | CapSure Fixation System - Straight 5mm x 37 cm 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm 15 Permanent fasteners | GDW | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| July 30, 2015 | K151177 | XenMatrix AB Surgical Graft | PIJ | Substantially Equivalent | C. R. Bard | accessdata.fda.gov |
| March 25, 2015 | K142706 | Modified ONFLEX Mesh | FTL | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| March 20, 2015 | K142711 | ONFLEX Mesh | FTL | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| March 12, 2015 | K142873 | OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fasteners | GDW | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| May 21, 2014 | K140533 | GALAFLEX MESH | OOD | Substantially Equivalent | Tepha, Inc. | accessdata.fda.gov |
| April 28, 2014 | K140501 | XENMATRIX SURGICAL GRAFT | FTM | Substantially Equivalent | C. R. Bard | accessdata.fda.gov |
| December 13, 2013 | K132441 | BARD VENTRALEX HERNIA PATCH | FTL | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| May 1, 2013 | K130968 | VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM | FTL | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| October 22, 2012 | K120728 | PHASIX PLUG AND PATCH | OWT | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| May 24, 2011 | K111153 | SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEM | GDW | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| March 23, 2011 | K101928 | VENTRALEX ST HERNIA PATCH | FTL | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| March 23, 2011 | K101920 | VENTRIO ST HERNIA PATCH | FTL | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| July 15, 2010 | K101851 | VENTRALIGHT ST MESH | FTL | Substantially Equivalent | Davol Inc., Sub. C. R. Bard, Inc. | accessdata.fda.gov |
| April 21, 2010 | K100229 | VENTRIO HERNIA PATCH | FTL | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| December 8, 2009 | K092032 | BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160 | FTL | Substantially Equivalent | Davol Inc., Sub. C. R. Bard, Inc. | accessdata.fda.gov |
| January 17, 2007 | K063739 | SEPRAMESH, MODEL 5959-1214 | FTL | Substantially Equivalent | Genzyme Corporation | accessdata.fda.gov |
| October 23, 2006 | K061754 | BARD COMPOSITE L/P MESH | FTL | Substantially Equivalent | Davol Inc., Sub. C. R. Bard, Inc. | accessdata.fda.gov |
| December 17, 2003 | K033666 | HEMADERM | QSY | Substantially Equivalent | Medafor, Inc. | accessdata.fda.gov |
| October 11, 1996 | K963141 | KUGEL HERNIA PATCH | FTL | Substantially Equivalent | Douglas Bueschel | accessdata.fda.gov |
| March 16, 1995 | K951086 | NEZHAT-DORSEY HYDRO-DISSECTION SYSTEM AND ACCESSORIES | GCJ | Substantially Equivalent | American Hydro-Surgical Instruments, Inc. | accessdata.fda.gov |
| March 6, 1995 | K946089 | NEZHAT-DORSEY(TM) REUSABLE ASPIRATION-VAC(TM) PROBES WITH AND WITHOUT PUNCTURE CANNULA | GCJ | Substantially Equivalent | American Hydro-Surgical Instruments, Inc. | accessdata.fda.gov |
| August 24, 1992 | K922916 | BARD MARLEX MESH DART | FTL | Substantially Equivalent | C.R. Bard, 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 |
|---|---|---|---|---|---|---|
| April 11, 2016 | P150016 | TRIDYNE VASCULAR SEALANT | NBE | 27 | March 12, 2026 | accessdata.fda.gov |
| January 14, 2010 | P010047 | PROGEL PLEURAL AIR LEAK SEALANT | NBE | 67 | March 12, 2026 | accessdata.fda.gov |
| 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 |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 25, 2026 | 98602 | Class II | Ongoing | Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030. | Potential for product to contain foreign matter, confirmed to be inspect fragments. | accessdata.fda.gov |
| April 25, 2023 | 92213 | Class II | Ongoing | Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460 | 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 | accessdata.fda.gov |
| June 27, 2022 | 90555 | Class II | Ongoing | X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000) | The device may potentially cause a fire, leading to a safety risk. | accessdata.fda.gov |
| June 7, 2022 | 90377 | Class II | Ongoing | HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction and Irrigation Tubing, Catalog number 0026880 | The product is not able to provide irrigation. | accessdata.fda.gov |
| October 8, 2014 | 69464 | Class II | Terminated | Bard PerFix Light Plug The Bard PerFix Light Plug is indicated for reinforcement if soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects. | The patient record peel-off label product code and size did not match the other labeling and actual product in the packaging for the Bard Small PerFix Light Plug. | accessdata.fda.gov |
| April 24, 2014 | 68124 | Class II | Terminated | Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. | Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. | accessdata.fda.gov |
| January 3, 2014 | 67149 | Class II | Terminated | Composix L/P with Echo PS 10" X 13" Product Code 0144113 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. Thi | Product labeling does not match product configuration. | accessdata.fda.gov |
| September 4, 2012 | 63069 | Class II | Terminated | Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Code 5954810. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is | Mislabeled: The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" package contains 8" x 10" VENTRALIGHT ST Mesh product | accessdata.fda.gov |
| October 4, 2011 | 60057 | Not yet classified | Terminated | Bard Ventralex" ST Medium Circle with Strap Hernia Patch Diameter 6.4cm /2.5", Catalog Number: 5950008. Intended for use in the reconstruction of soft tissue, where weakness exists, in procedures involving soft tissue re | Mislabeled: Bard Ventralex" ST Medium Circle was packaged in a pre-printed carton identified for a Bard Ventralex" ST Large Circle. | accessdata.fda.gov |
| April 25, 2011 | 58685 | Not yet classified | Terminated | Bard Soft Mesh 4"x6" (10cm x 15cm) Flat, Product Code: 0117010. The Bard Soft Mesh patch is a non-absorbable, sterile prosthesis. It has a large pore design and is constructed of knitted polypropylene monofilaments. The | Mislabeling: complaints of product labeled as Bard Soft Mesh 4" x 6" containing Bard Soft Mesh 6" x 6" | accessdata.fda.gov |
| April 11, 2011 | 58470 | Not yet classified | Terminated | BardVentralex" Hernia Patch Medium Circle with Strap Diameter 6.4cm /2.5",\ Catalog #0010302, lot number HUTL1283. The BardVentralex" Hernia Patch is a self-expanding, non-absorbable, sterile prosthesis. The device class | Mislabeled: Bard Medium Ventralex Hernia Patch 6.4cm /2.5" packaged in a pre-printed carton identified for a Bard Ventralex Small Circle 4.3cm /1.7" | accessdata.fda.gov |
| January 7, 2011 | 57566 | Not yet classified | Terminated | XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 10 x 15 cm Rectangle Catalog #: 1161015 | Davol cannot guarantee that all Xenomatic product released from July to October 2010 meets FDA guidelines for endotoxin limits; and therefore, the grafts are potentially contaminated with bacteria. | accessdata.fda.gov |
| October 15, 2010 | 57010 | Not yet classified | Terminated | BARD Ventrio Small Oval Hernia Patch 3.1" x 4.7" Product Code: 0010211 Indicated for use in the reconstruction of soft tissue deficiencies such as for the repair of hernias. | Mislabeled: Hernia Patch may be a different size than on the product label | accessdata.fda.gov |
| October 15, 2010 | 57008 | Not yet classified | Terminated | BARD Mesh Pre-shaped (1.8" x 4.0"/4.5cm x 10cm) Product code: 0112700 Intended use: Bard Pre-shaped mesh is a pre-shaped mesh constructed of knitted polypropylene monofilaments. It is indicated for the repair of inguinal | Mislabeled: The labeled BARD Mesh Pre-shaped product code 0112700 (1.8" x 4.0"/4.5cm x 10cm), but the contents are the BARD Mesh Large Pre-shaped product code 0113700 (2.4" x 5.4"/6.0cm x 13.7cm). | accessdata.fda.gov |
| April 8, 2010 | 55251 | Not yet classified | Terminated | Bard Ventrio Small Oval Hernia Patch 8cm X 12cm (3.1" x 4.7"), Warwick, RI Product Code: 0010211 The Ventrio Hernia Patch is a self-expanding non-absorbable, sterile prosthesis, containing two primary layers of monofilam | Mislabeled: Product labeled as Small Oval (3.1" x 4.7") may contain Small Circle (3.0") | accessdata.fda.gov |
| July 30, 2009 | 52768 | Not yet classified | Terminated | BARD Simpulse" SOLO System with Soft Splash Shield Tip Product Code: 0067590. The Simpulse SOLO Suction/Irrigator is designed to provide controlled powered irrigation during open orthopedic and general surgical procedure | Product sterility may be compromised due to lack of package integrity. | accessdata.fda.gov |
| December 8, 2008 | 50479 | Not yet classified | Terminated | Bard 3D Max Mesh, Left large, Sterile Pre-formed Knitted Polypropylene Product Code: 0151531 Bard 3D Max Mesh is an anatomically shaped pre-formed polypropylene mesh indicated for use in the repair of hernias and chest w | Mislabeled: Product labeled as Left large, may contain a Right Large | accessdata.fda.gov |
| July 16, 2007 | 38634 | Not yet classified | Terminated | Davol Salute Fixation Reusable Handle Item Code: 0113024-Product Code 9113024 (Refurbished) | Malformed constructs (straight shots) may form causing injury to user/patient | accessdata.fda.gov |
| January 10, 2007 | 36990 | Not yet classified | Completed | Bard Composix Kugel Hernia Patch- Large Oval with ePTFE, 5.4'' x 7.0'' Product Number: 0010202 | PET recoil ring breakage-Memory recoil ring may break which could potentially lead to bowel perforation and or chronic enteric fistula | accessdata.fda.gov |
| December 27, 2006 | 36922 | Not yet classified | Terminated | Davol Salute Fixation System, 38cm Reusable Shaft (Laparoscopic) with Handle. To attach mesh to the abdominal wall. Reference Number 0113036 or 9113036(refurbished) | Inadequate directions for use in the Salute System. Labeling -Revised to provide updated instructions for use and proper servicing | accessdata.fda.gov |
| December 22, 2005 | 34393 | Not yet classified | Completed | Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 8.7'' x 10.7'' Code: 0010206 | Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula | accessdata.fda.gov |
Compare with other makers
- All makers of Mesh, Surgical, Absorbable, Abdominal Hernia
- All makers of Surgical Film
- All makers of Mesh, Surgical, Polymeric
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Mesh, Surgical, Deployer
- All makers of Staple, Implantable
Updated September 28, 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.