Company ยท US
Davol, Inc., Sub. C. R. Bard, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2010. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (0 in 12 months)
32recalls (0 in 12 months)
24recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FTL | Mesh, Surgical, Polymeric | 25 |
| GDW | Staple, Implantable | 11 |
| HIG | Insufflator, Hysteroscopic | 5 |
| FTM | Mesh, Surgical | 4 |
| GCJ | Laparoscope, General & Plastic Surgery | 3 |
| HRX | Arthroscope | 3 |
| FHQ | Holder, Needle, Gastroenterologic | 1 |
| FQH | Lavage, Jet | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| GEX | Powered Laser Surgical Instrument | 1 |
| GWD | Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 15, 2010 | K101851 | VENTRALIGHT ST MESH Davol Inc., Sub. C. R. Bard, Inc. | FTL |
| Dec 8, 2009 | K092032 | BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160 Davol Inc., Sub. C. R. Bard, Inc. | FTL |
| Oct 7, 2008 | K081010 | BARD 3DMAX MESH Davol Inc., Sub. C. R. Bard, Inc. | FTL |
| Oct 23, 2006 | K061754 | BARD COMPOSITE L/P MESH Davol Inc., Sub. C. R. Bard, Inc. | FTL |
| Jun 2, 2006 | K061314 | BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH Davol Inc., Sub. C. R. Bard, Inc. | FTL |
| Aug 11, 2005 | K051848 | SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079 Davol Inc., Sub. C. R. Bard, Inc. | GDW |
| May 25, 2005 | K050610 | SALUTE FIXATION SYSTEM Davol Inc., Sub. C. R. Bard, Inc. | GDW |
| Aug 16, 2001 | K011069 | AQUASENS FLUID MONITORING SYSTEM Davol Inc., Sub. C. R. Bard, Inc. | HIG |
| Dec 8, 2000 | K003674 | NEZHAT-DORSEY REUSABLE ELECTROSURGICAL ATTACHMENTS: J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, NEEDLE TIP, BALL TIP Davol Inc., Sub. C. R. Bard, Inc. | GEI |
| Sep 13, 1999 | K991799 | DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO Davol Inc., Sub. C. R. Bard, Inc. | HIG |
| Jun 22, 1999 | K991637 | BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700 Davol Inc., Sub. C. R. Bard, Inc. | FTL |
| Feb 19, 1999 | K982867 | HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000 Davol Inc., Sub. C. R. Bard, Inc. | HIG |
| Dec 11, 1997 | K970078 | HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM Davol Inc., Sub. C. R. Bard, Inc. | HIG |
| Aug 6, 1997 | K971745 | BARD COMPOSITE PROSTHESIS Davol Inc., Sub. C. R. Bard, Inc. | FTL |
| Mar 4, 1997 | K964879 | PNEUMATIC ARTHROSCOPY PULSED IRRIGATOR SYSTEM MODEL 0027030 AND BATTERY ARTHROSCOPY PULSED IRRIGATOR SYSTEM Davol Inc., Sub. C. R. Bard, Inc. | HRX |
| Dec 2, 1996 | K964211 | DAVOL PLUME FILTER (5541420) Davol Inc., Sub. C. R. Bard, Inc. | GEX |
| May 16, 1996 | K961224 | HYDRO-FLEX LI LAPAROSCOPIC IRRIGATION SYSTEM Davol Inc., Sub. C. R. Bard, Inc. | GCJ |
| May 15, 1996 | K961492 | HYDRO-SURG LAPAROSCOPIC IRRIGATON MODELS 0026000. 0026010 Davol Inc., Sub. C. R. Bard, Inc. | GCJ |
| Sep 26, 1995 | K953577 | BARD VISILEX MESH 3 X 6 Davol Inc., Sub. C. R. Bard, Inc. | FTL |
| Jun 2, 1995 | K951026 | DAVOL ARTHRO-FLO 3 Davol Inc., Sub. C. R. Bard, Inc. | HRX |
| Dec 30, 1994 | K933384 | BARD HYSTERO-FLO II PUMP Davol Inc., Sub. C. R. Bard, Inc. | HIG |
| Sep 16, 1994 | K935617 | ARTHRO-FLO IRRIGATION SYSTEM MODIFICATION Davol Inc., Sub. C. R. Bard, Inc. | HRX |
| Jul 19, 1994 | K942886 | SIMPULSE SOLO SUCTION IRRIGATOR Davol Inc., Sub. C. R. Bard, Inc. | FQH |
| May 17, 1994 | K936102 | DAVOL LAPAROSCOPIC INSUFFLATION NEEDLE FOR GENERAL LAPAROSCOPIC PROCEDURES Davol Inc., Sub. C. R. Bard, Inc. | GCJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 1, 2011 | Davol, Inc., Sub. C. R. Bard, Inc. 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 inv Terminated |
FTL | K101928 |
| May 23, 2011 | Davol, Inc., Sub. C. R. Bard, Inc. 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 polypropy Terminated |
FTL | K033814 |
| May 2, 2011 | Davol, Inc., Sub. C. R. Bard, Inc. 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 prosth Terminated |
FTL | K021736 |
| Mar 2, 2011 | Davol, Inc., Sub. C. R. Bard, Inc. XenMatrix Surgical Graft ,Sterile, Porcine Dermal Matrix
19 x 35 cm Rectangle
Catalog #: 1161935 Terminated |
FTM | K081272 |
| Mar 2, 2011 | Davol, Inc., Sub. C. R. Bard, Inc. XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix
19 x 28 cm Rectangle
Catalog #: 1161928 Terminated |
FTM | K081272 |
| Mar 2, 2011 | Davol, Inc., Sub. C. R. Bard, Inc. XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix
15 x 20 cm Rectangle
Catalog #: 1161520 Terminated |
FTM | K081272 |
| Mar 2, 2011 | Davol, Inc., Sub. C. R. Bard, Inc. XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix
10 x 15 cm Rectangle
Catalog #: 1161015 Terminated |
FTM | K081272 |
| Nov 23, 2010 | Davol, Inc., Sub. C. R. Bard, Inc. 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 Terminated |
FTL | K052155 |
| Nov 19, 2010 | Davol, Inc., Sub. C. R. Bard, Inc. BARD Ventrio Small Circle Hernia Patch 3.0"
Product Code: 0010213
Indicated for use in the reconstruction of soft tissue deficiencies such as for the repair of hernias. Terminated |
FTL | K081777 |
| Nov 19, 2010 | Davol, Inc., Sub. C. R. Bard, Inc. BARD Ventrio Large Oval Hernia Patch 5.4" x 7.0"
Product Code: 0010212
Indicated for use in the reconstruction of soft tissue deficiencies such as for the repair of hernias. Terminated |
FTL | K081777 |
| Nov 19, 2010 | Davol, Inc., Sub. C. R. Bard, Inc. 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. Terminated |
FTL | K081777 |
| May 4, 2010 | Davol, Inc., Sub. C. R. Bard, Inc. 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 prima Terminated |
FTL | K081777 |
| Sep 6, 2009 | Davol, Inc., Sub. C. R. Bard, Inc. 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 gene Terminated |
FHQ | None listed |
| Jan 28, 2009 | Davol, Inc., Sub. C. R. Bard, Inc. 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 o Terminated |
FTL | K792281 |
| Sep 27, 2007 | Davol, Inc., Sub. C. R. Bard, Inc. Davol Salute Short 18cm Sterile Implant Cartridge - 30 Q-ring;5/Box, Item Number: 0113061 Terminated |
GDW | None listed |
| Sep 27, 2007 | Davol, Inc., Sub. C. R. Bard, Inc. Davol Salute Short 18cm Sterile Implant Cartridge - 10 Q-ring;5/Box, Item Number: 0113043 Terminated |
GWD | K050610 |
| Sep 27, 2007 | Davol, Inc., Sub. C. R. Bard, Inc. Davol Salute Laproscopic 38cm Sterile Implant Cartridge 60 Q-ring;5/Box, Item Number: 0113059 Terminated |
GDW | None listed |
| Sep 27, 2007 | Davol, Inc., Sub. C. R. Bard, Inc. Davol Salute Laproscopic 38cm Sterile Implant Cartridge, Sterile- 30 Q-ring;5/Box, Item Number: 0113035 Terminated |
GDW | K050610 |
| Sep 27, 2007 | Davol, Inc., Sub. C. R. Bard, Inc. Davol Salute Laproscopic 38cm Sterile Implant Cartridge, Sterile- 10 Q-ring;5/Box, Item Number: 0113058 Terminated |
GDW | K050610 |
| Sep 27, 2007 | Davol, Inc., Sub. C. R. Bard, Inc. Davol Salute Reusable 18cm Shaft (Short/Open)
Item Numbers: 0113037-Product Code: 9113037(Refurbished) Terminated |
GDW | K050610 |
| Sep 27, 2007 | Davol, Inc., Sub. C. R. Bard, Inc. Davol Salut Fixation Reusable 38cm Shaft (Laparoscopic)
Item Numbers: 0113036-Product Code 9113036-(Refurbished) Terminated |
GDW | K050610 |
| Sep 27, 2007 | Davol, Inc., Sub. C. R. Bard, Inc. Davol Salute Fixation Reusable Handle
Item Code: 0113024-Product Code 9113024 (Refurbished) Terminated |
GDW | K050610 |
| Feb 1, 2007 | Davol, Inc., Sub. C. R. Bard, Inc. Davol Salute Fixation System, 18cm Reusable Shaft (Short/Open) with Handle. To attach mesh to the abdominal wall.
Reference Number 0113037 or 9113037(refurbished) Terminated |
GDW | K050610 |
| Feb 1, 2007 | Davol, Inc., Sub. C. R. Bard, Inc. Davol Salute Fixation System, 38cm Reusable Shaft (Laparoscopic) with Handle. To attach mesh to the abdominal wall.
Reference Number 0113036 or 9113036(refurbished) Terminated |
GDW | K050610 |
| Jan 30, 2007 | Davol, Inc., Sub. C. R. Bard, Inc. Bard Composix Kugel Hernia Patch-
Large Circle 4.5'' with ePTFE
Product Code: 0010204 Completed |
FTL | K003323 |
| Jan 30, 2007 | Davol, Inc., Sub. C. R. Bard, Inc. Bard Composix Kugel Hernia Patch-
Large Oval with ePTFE , 5.4'' x 7.0''
Product Number: 0010202 Completed |
FTL | K003323 |
| Feb 22, 2006 | Davol, Inc., Sub. C. R. Bard, Inc. Bard Composix Kugel Oval, 6.3'' x 12.3'' for hernia repairs
Product Code: 0010209 Completed |
FTL | None listed |
| Feb 22, 2006 | Davol, Inc., Sub. C. R. Bard, Inc. Bard Composix Kugel Large Circle, 4.5'' for hernia repairs
Product Code: 0010204 Completed |
FTL | None listed |
| Feb 22, 2006 | Davol, Inc., Sub. C. R. Bard, Inc. Bard Composix Kugel Large Oval, 5.4'' x 7'' for hernia repairs
Product Code: 0010202 Completed |
FTL | None listed |
| Feb 22, 2006 | Davol, Inc., Sub. C. R. Bard, Inc. Bard Composix Kugel Mesh X-Large Patch
Oval with ePTFE, 7.7'' x 9.7'' (19.6cm x 24.6cm)
Code: 0010208 Completed |
FTL | None listed |
| Feb 22, 2006 | Davol, Inc., Sub. C. R. Bard, Inc. Bard Composix Kugel Mesh X-Large Patch
Oval with ePTFE, 10.8'' x 13.7'' (25.4cm x 33cm)
Code: 0010207 Completed |
FTL | None listed |
| Feb 22, 2006 | Davol, Inc., Sub. C. R. Bard, Inc. Bard Composix Kugel Mesh X-Large Patch
Oval with ePTFE, 8.7'' x 10.7''
Code: 0010206 Completed |
FTL | K003323 |