Medical device makerLabelled 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 Summit Medical with 14 510(k) clearances and 4 device recalls. The most recent is a device recall dated Jan 13, 2023: Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile..
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.
| Jan 13, 2023 | Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.Class II · Sterile product pouches were not sealed. | Device recalls |
| Nov 16, 2018 | InstruSafe(R) Sterilization ContainerK180528 · KCT | 510(k) clearances |
| May 18, 2018 | GRAFTSITEK173110 · BSP | 510(k) clearances |
| Jul 25, 2017 | ANCHORMAN Tibial Ligament Fixation DeviceK170388 · MBI | 510(k) clearances |
| Apr 11, 2017 | MINNE TIES MMF Suture SystemK162046 · DYX | 510(k) clearances |
| Aug 18, 2015 | Instru-Safe Instrument Protection SystemK151166 · KCT | 510(k) clearances |
| Jun 22, 2015 | Instru-Safe Instrument Protection SystemK150540 · KCT | 510(k) clearances |
| May 29, 2015 | Instru-Safe Instrument Protection SystemK142768 · KCT | 510(k) clearances |
| Dec 23, 2014 | Instru-Safe Instrument Protection SystemK142630 · KCT | 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
