Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 7 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Qapel Medical Inc. with 9 510(k) clearances, 1 device recall and 1 warning letter. The most recent is a device recall dated Feb 26, 2025: Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: ….
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.
| Feb 26, 2025 | Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132. Hippo 072 Aspiration System includinClass I · Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, ve | Device recalls |
| Feb 5, 2025 | Warning letter: Complaint handling, MDR reporting, Design controlsCDRH | Warning letters |
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
