Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA files no records under this name; these are its 3 companies' records, each linked to the record.
As of Nov 14, 2026, FDA's public records list Freudenberg Group and its 3 subsidiaries with 5 510(k) clearances and 4 device recalls. The most recent is a 510(k) clearance dated Dec 18, 2024: FirstFit Surgical Kit.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Freudenberg Group and its 3 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 18, 2024 | FirstFit Surgical KitK240763 · EWL | 510(k) clearances |
| Feb 21, 2022 | Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)Class II · Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripher | Device recalls |
| Feb 21, 2022 | Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)Class II · Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripher | Device recalls |
| Feb 5, 2021 | Freudenberg Surgical MaskK210063 · FXX | 510(k) clearances |
| Oct 4, 2019 | Steerable Introducer 12FK192422 · DRA | 510(k) clearances |
| Aug 1, 2019 | Steerable IntroducerK191190 · DYB | 510(k) clearances |
| May 30, 2019 | FlexSeal Introducer Sheath with Hydrophilic CoatingK190628 · DYB | 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
