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 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Bolder Surgical with 5 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Nov 15, 2023: CoolSeal Trinity.
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.
| Nov 15, 2023 | CoolSeal TrinityK231012 · GEI | 510(k) clearances |
| Jan 25, 2022 | CoolSeal Generator, REF: CSL-200-50Class II · A potential manufacturing/assembly defect could result in the generator not meeting IEC 60601 standards for medical elec | Device recalls |
| Sep 7, 2021 | CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)K211579 · GEI | 510(k) clearances |
| May 6, 2021 | CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)K203183 · GEI | 510(k) clearances |
| May 6, 2021 | CoolSeal RevealK203640 · GEI | 510(k) clearances |
| Oct 6, 2020 | CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20K202114 · GEI | 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
