FDA applicant
Erbe Elektromedizin GmbH
FDA records 16 decisions for Erbe Elektromedizin GmbH (Tuebingen, DE) from 1994 to 2026: 16 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and GEH (Unit, Cryosurgical, Accessories). Since 2016 its 510(k)s took a median of 134 days from receipt to decision, against 113 for FDA’s reviews in the same codes and years. Its devices cite 26 predicates, 9 of them its own earlier devices. 4 recalls are linked to its devices, 3 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Erbe Elektromedizin GmbH’s devices, and how often a recall has named them.
FDA decisions per year
4in 2025
2026 so far, outlined.
Recalls per year
4in 2026
Class I Class II/III not classified
Planning a device like Erbe Elektromedizin GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Erbe”
FDA records each applicant name separately; these may or may not be the same firm.