Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in GermanyLabelled 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 13, 2026, FDA's public records list Trokamed GmbH with 4 510(k) clearances and 4 device recalls. The most recent is a device recall dated Nov 27, 2024: Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overt….
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.
| Date | Record | Source |
|---|---|---|
| Nov 27, 2024 | Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.Class I · If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments an | Device recalls |
| Nov 27, 2024 | Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.Class I · If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments an | Device recalls |
| Nov 27, 2024 | Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.Class I · If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments an | Device recalls |
| Nov 27, 2024 | Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.Class I · If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments an | Device recalls |
| Jul 30, 2021 | Mini PCNL-SystemK200770 · FED | 510(k) clearances |
| Mar 1, 2011 | TROKAMED MORCELLATORK091010 · HET | 510(k) clearances |
| Jul 19, 2006 | TROKAMED GMBH ENDOSCOPES AND ACCESSORIESK060233 · GCJ | 510(k) clearances |
| Jul 12, 2006 | TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIESK060232 · 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
