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 15, 2026, FDA's public records list ERBE Elektromedizin and its 2 subsidiaries with 57 510(k) clearances and 7 device recalls. The most recent is a 510(k) clearance dated Jun 9, 2026: ERBECRYO 2 Cryosurgical Unit and Accessories.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, ERBE Elektromedizin and its 2 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 9, 2026 | ERBECRYO 2 Cryosurgical Unit and AccessoriesK261806 · GEH | 510(k) clearances |
| Apr 22, 2026 | ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeK253230 · GEH | 510(k) clearances |
| Mar 31, 2026 | ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap Set for Olympus ScoClass II · Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector confi | Device recalls |
| Mar 31, 2026 | ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20Class II · Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector confi | Device recalls |
| Mar 31, 2026 | ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222Class II · Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector confi | Device recalls |
| Dec 18, 2025 | MOVIVA® Hybrid Ablation ProbeK253915 · GEI | 510(k) clearances |
| Aug 29, 2025 | Erbe ESU Model VIO® 3n with AccessoriesK251108 · GEI | 510(k) clearances |
| Jun 20, 2025 | HybridAPC probeK243120 · GEI | 510(k) clearances |
| Mar 21, 2025 | FiAPC plus probesK243451 · GEI | 510(k) clearances |
| Aug 26, 2024 | FiAPC plus probesK242044 · GEI | 510(k) clearances |
| Aug 5, 2024 | HybridTherm SystemK240932 · 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
