Davol Inc., Sub. C.R. Bard, Inc.
Warwick, RI, US
DAVOL INC., SUB. C.R. BARD, INC. appears in FDA device records in Warwick, RI. FDA records list 24 510(k) clearances between and , 85 PMA records and one registered establishment. As of , FDA records show 60 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to Davol Inc., Sub. C.R. Bard, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Davol Inc., Sub. C. R. Bard, Inc.510(k), PMA, recall
- Davol, Inc.PMA, recall
- Davol, Inc., Subs. C. R. Bard, Inc.enforcement report, recall
510(k) clearance history
FDA records hold 24 510(k) clearances for Davol Inc., Sub. C.R. Bard, Inc. between 1994 and 2010. The busiest year on record is 1994, with 4. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 4 |
| 1995 | 2 |
| 1996 | 3 |
| 1997 | 3 |
| 1999 | 3 |
| 2000 | 1 |
| 2001 | 1 |
| 2005 | 2 |
| 2006 | 2 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K101851 | VENTRALIGHT ST MESH | FTL | Substantially Equivalent | |
| K092032 | BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160 | FTL | Substantially Equivalent | |
| K081010 | BARD 3DMAX MESH | FTL | Substantially Equivalent | |
| K061754 | BARD COMPOSITE L/P MESH | FTL | Substantially Equivalent | |
| K061314 | BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH | FTL | Substantially Equivalent | |
| K051848 | SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079 | GDW | Substantially Equivalent | |
| K050610 | SALUTE FIXATION SYSTEM | GDW | Substantially Equivalent | |
| K011069 | AQUASENS FLUID MONITORING SYSTEM | HIG | Substantially Equivalent | |
| K003674 | NEZHAT-DORSEY REUSABLE ELECTROSURGICAL ATTACHMENTS: J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, NEEDLE TIP, BALL TIP | GEI | Substantially Equivalent | |
| K991799 | DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO | HIG | Substantially Equivalent | |
| K991637 | BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700 | FTL | Substantially Equivalent | |
| K982867 | HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000 | HIG | Substantially Equivalent | |
| K970078 | HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM | HIG | Substantially Equivalent | |
| K971745 | BARD COMPOSITE PROSTHESIS | FTL | Substantially Equivalent | |
| K964879 | PNEUMATIC ARTHROSCOPY PULSED IRRIGATOR SYSTEM MODEL 0027030 AND BATTERY ARTHROSCOPY PULSED IRRIGATOR SYSTEM | HRX | Substantially Equivalent | |
| K964211 | DAVOL PLUME FILTER (5541420) | GEX | Substantially Equivalent | |
| K961224 | HYDRO-FLEX LI LAPAROSCOPIC IRRIGATION SYSTEM | GCJ | Substantially Equivalent | |
| K961492 | HYDRO-SURG LAPAROSCOPIC IRRIGATON MODELS 0026000. 0026010 | GCJ | Substantially Equivalent | |
| K953577 | BARD VISILEX MESH 3 X 6 | FTL | Substantially Equivalent | |
| K951026 | DAVOL ARTHRO-FLO 3 | HRX | Substantially Equivalent | |
| K933384 | BARD HYSTERO-FLO II PUMP | HIG | Substantially Equivalent | |
| K935617 | ARTHRO-FLO IRRIGATION SYSTEM MODIFICATION | HRX | Substantially Equivalent | |
| K942886 | SIMPULSE SOLO SUCTION IRRIGATOR | FQH | Substantially Equivalent | |
| K936102 | DAVOL LAPAROSCOPIC INSUFFLATION NEEDLE FOR GENERAL LAPAROSCOPIC PROCEDURES | GCJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1213643 | 1213643 | DAVOL INC., SUB. C.R. BARD, INC. | 100 Crossings Blvd, Warwick, RI 02886 US | 2026 | and 10 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LMFAgent, Absorbable Hemostatic, Collagen Based
- LMGAgent, Absorbable Hemostatic, Non-Collagen Based
- HRXArthroscope
- PIJCollagen Surgical Mesh Containing Drugs
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics
- MDMInstrument, Manual, Surgical, General Use
- HIGInsufflator, Hysteroscopic
- GCJLaparoscope, General & Plastic Surgery
- FQHLavage, Jet
- FTMMesh, Surgical
- OWTMesh, Surgical, Absorbable, Abdominal Hernia
- OXCMesh, Surgical, Absorbable, Staple Line Reinforcement
- OWZMesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction
- OWVMesh, Surgical, Collagen, Diaphragmatic Hernia
- OXHMesh, Surgical, Collagen, Plastic And Reconstructive Surgery
- ORQMesh, Surgical, Deployer
- OQLMesh, Surgical, Deployment Balloon
- FTLMesh, Surgical, Polymeric
- NHBPolymer, Ear, Nose And Throat, Synthetic, Absorbable
- GEXPowered Laser Surgical Instrument
- NBESealant, Polymerizing
- LYASplint, Intranasal Septal
- GDWStaple, Implantable
- OODSurgical Film
Recall records
Showing 25 of 60| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1896-2026 | 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. | Class II | Open, Classified | |
| Z-2244-2023 | Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955460G (EU Only) | 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 | Class II | Open, Classified | |
| Z-2243-2023 | Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450G (EU only) | 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 | Class II | Open, Classified | |
| Z-2242-2023 | Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450 | 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 | Class II | Open, Classified | |
| Z-2241-2023 | 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 | Class II | Open, Classified | |
| Z-1457-2022 | 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. | Class II | Open, Classified | |
| Z-1305-2022 | HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irrigation Tubing, Catalog Number 0026870 | The product is not able to provide irrigation. | Class II | Open, Classified | |
| Z-1304-2022 | 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. | Class II | Open, Classified | |
| Z-0191-2015 | 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. | Class II | Terminated | |
| Z-1696-2014 | Bard Ventralight" ST Mesh with Echo PS" 8"x10" Reorder Number: 5955810 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. | Class II | Terminated | |
| Z-1695-2014 | Bard Ventralight" ST Mesh with Echo PS" 8" Circle Number: 5955800 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. | Class II | Terminated | |
| Z-1694-2014 | Bard Ventralight" ST Mesh with Echo PS TM 7"x9" Reorder Number: 5955790 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. | Class II | Terminated | |
| Z-1693-2014 | Bard Ventralight" ST Mesh with Echo PS" 6"x8" Reorder Number: 5955680 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. | Class II | Terminated | |
| Z-1692-2014 | Bard Ventralight" ST Mesh with Echo PS" 6"x10" Reorder Number: 5955610 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. | Class II | Terminated | |
| Z-1691-2014 | Bard Ventralight" ST Mesh with Echo PS" 6" CircleReorder Number: 5955600 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. | Class II | Terminated | |
| Z-1690-2014 | Bard Ventralight" ST Mesh with Echo PS" 4"x6" Reorder Number: 5955460 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. | Class II | Terminated | |
| Z-1689-2014 | Bard Ventralight" ST Mesh with Echo PS" 4.5" Circle Reorder Number: 5955450 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. | Class II | Terminated | |
| Z-1688-2014 | Bard Ventralight" ST Mesh with Echo PS" 12"x14" Reorder Number: 5955124 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. | Class II | Terminated | |
| Z-1687-2014 | BardVentralight" ST Mesh with Echo PS" 10"x13" Reorder Number: 5955113 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. | Class II | Terminated | |
| Z-1686-2014 | Bard Composix" LIP Mesh with Echo PS" 8"x10" Reorder Number: 0144810 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. | Class II | Terminated | |
| Z-1685-2014 | Bard Composix" LIP Mesh with Echo PS" 7"x9" Reorder Number: 0144790 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. | Class II | Terminated | |
| Z-1684-2014 | Composix" LP with Echo PS" 6x8 Reorder Number: 0144680 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. | Class II | Terminated | |
| Z-1683-2014 | Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 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. | Class II | Terminated | |
| Z-1682-2014 | 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. | Class II | Terminated | |
| Z-0820-2014 | Composix L/P with Echo PS 6" X 8" Product Code 0144680 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair. | Product labeling does not match product configuration. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain