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.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Insightra Medical Inc with 4 510(k) clearances, 1 device recall and 1 warning letter. The most recent is a device recall dated Jul 19, 2025: Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalo….
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.
| Jul 19, 2025 | Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, anClass II · Device contains indications for use and device compatibility claims that have not be reviewed and approved for safety an | Device recalls |
| Jun 3, 2025 | Warning letter: CAPA, Complaint handling, MDR reportingCDRH | Warning letters |
| May 7, 2015 | Insightra Freedom Ventral Hernia Repair SystemK142192 · FTL | 510(k) clearances |
| Jun 10, 2014 | FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISKK140967 · FTL | 510(k) clearances |
| Aug 23, 2012 | FREEDOM INGUINAL HERNIA IMPLANTK113552 · FTL | 510(k) clearances |
| Jan 12, 2009 | ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20K082746 · DSP | 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
