Davol, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 7
- 510(k) Clearances
- 50
- Inspections
- 11
- Compliance Actions
- 0
Known Names
davol, davol inc., sub. c. r. bard
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2243-2023 | Class II | Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a | April 25, 2023 |
| Z-2242-2023 | Class II | Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with | April 25, 2023 |
| Z-2241-2023 | Class II | Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460 | April 25, 2023 |
| Z-2244-2023 | Class II | Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a | April 25, 2023 |
| Z-1457-2022 | Class II | X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog | June 27, 2022 |
| Z-1304-2022 | Class II | HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with | June 7, 2022 |
| Z-1305-2022 | Class II | HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoi | June 7, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251557 | Bard® Mesh; Bard® Mesh Pre-Shaped | June 12, 2025 |
| K250098 | Bard Soft Mesh; Bard Soft Mesh Pre-Shaped | April 9, 2025 |
| K031213 | AQUASENS FLUID MONITORING SYSTEM | April 30, 2003 |
| K030307 | DAVOL ARTHROVENT OUTFLOW TUBING | February 13, 2003 |
| K003323 | COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 | January 22, 2001 |
| K003790 | DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 55 | December 22, 2000 |
| K931899 | DAVOL ATS | November 15, 1994 |
| K941334 | DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE | June 14, 1994 |
| K921405 | DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP | March 25, 1994 |
| K935503 | DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET | March 7, 1994 |
| K926479 | BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM | March 1, 1994 |
| K931552 | DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT | October 8, 1993 |
| K932327 | THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM | July 13, 1993 |
| K930147 | SURGICAL MESH DELIVERY SYSTEM, GENERAL SURGERY | June 22, 1993 |
| K924144 | ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (CTR) | April 8, 1993 |
| K924592 | DAVOL KNOT PUSHER | December 17, 1992 |
| K914119 | DAVOL ORTHOPAEDIC AUTOTRANSFUSION SYSTEM | December 3, 1992 |
| K921755 | 8 FR SINGLE LUMEN HIGH PERF. GROSHONG CENT. VENOUS | October 23, 1992 |
| K922526 | DAVOL LAPAROSCOPIC LOOP AND RETRIEVAL DEVICES | September 2, 1992 |
| K920659 | DAVOL ENDO-FLO LASER PROBE AND ACCESSORIES | June 5, 1992 |