Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Becton DickinsonLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 6 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Davol, Inc. with 80 510(k) clearances and 8 device recalls. The most recent is a 510(k) clearance dated Sep 28, 2026: Phasix ST Parastomal Hernia Mesh.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 28, 2026 | Phasix ST Parastomal Hernia MeshK261543 · OWT | 510(k) clearances |
| Mar 25, 2026 | Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.Class II · Potential for product to contain foreign matter, confirmed to be inspect fragments. | Device recalls |
| Jul 24, 2025 | Onflex™ MeshK251955 · FTL | 510(k) clearances |
| Jun 12, 2025 | Bard® Mesh; Bard® Mesh Pre-ShapedK251557 · FTL | 510(k) clearances |
| Apr 9, 2025 | Bard Soft Mesh; Bard Soft Mesh Pre-ShapedK250098 · FTL | 510(k) clearances |
| Feb 19, 2025 | Phasix ST Umbilical Hernia PatchK243241 · OWT | 510(k) clearances |
| Jun 14, 2024 | 3DMax Light MeshK241250 · FTL | 510(k) clearances |
| Nov 1, 2023 | Bard 3DMax MeshK233402 · FTL | 510(k) clearances |
| Apr 25, 2023 | Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning systeClass II · Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may | Device recalls |
| Apr 25, 2023 | Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning systeClass II · Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may | Device recalls |
| Apr 25, 2023 | Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning sysClass II · Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may | Device recalls |
| Apr 25, 2023 | Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460Class II · Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may | Device recalls |
| Jun 27, 2022 | X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)Class II · The device may potentially cause a fire, leading to a safety risk. | Device recalls |
| Jun 7, 2022 | HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irrigation Tubing, CataClass II · The product is not able to provide irrigation. | Device recalls |
| Jun 7, 2022 | HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction and Irrigation Tubing,Class II · The product is not able to provide irrigation. | Device recalls |
| Jul 16, 2019 | OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 FastenersK191287 · GDW | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
