Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Integra Limited with 9 device recalls. The most recent is a device recall dated Mar 31, 2019: Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wo….
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.
| Mar 31, 2019 | Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the treatment of tunneliClass II · Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months | Device recalls |
| Mar 1, 2019 | Integra bioBLOCK Resorbable subtaler Implant, 10mm Catalog Number: 40010 - Product Usage: The bioBLOCK Implant is indicated for internal Class II · Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the p | Device recalls |
| Mar 1, 2019 | Integra bioBLOCK Resorbable subtaler Implant, 12mm Catalog Number: 040012 - Product Usage: The bioBLOCK Implant is indicated for internalClass II · Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the p | Device recalls |
| Mar 1, 2019 | Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - Product Usage: The bioBLOCK Implant is indicated for internalClass II · Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the p | Device recalls |
| Sep 10, 2013 | Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 11Class II · Integra LifeSciences has identified through an internal evaluation that in order to comply with US FDA requirements, ce | Device recalls |
| Jul 17, 2013 | Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla Retraction System, as part of the Ruggles bClass II · As a result of complaint investigations it was identified that there is a potential that the Leyla Ball Joint Clamp (R23 | Device recalls |
| Jul 27, 2012 | The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in tClass II · An investigation of customer complaints identified that for two product lots, Left Horseshoe Gel Pads were packaged as a | Device recalls |
| Jul 27, 2012 | The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in tClass II · An investigation of customer complaints identified that for two product lots, Left Horseshoe Gel Pads were packaged as a | Device recalls |
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
