Data / Medical devices / Mediastinoscope, Surgical
Mediastinoscope, Surgical (EWY): 14 FDA-registered makers in 2 countries
14 establishments in 2 countries are registered with the FDA to make Mediastinoscope, Surgical (product code EWY, Class 2, 21 CFR 874.4720). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 11 510(k) clearances under this code, the latest on March 2, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EWY
- Device class
- 2
- Regulation
- 874.4720
- Medical specialty
- Ear, Nose, Throat
Makers by country
| Country | Makers |
|---|---|
| Germany | 11 |
| United States | 3 |
Makers of Mediastinoscope, Surgical
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Karl Storz Se & Co KG | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer | 3 | March 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| Olympus Winter & Ibe GMBH | Hamburg, Germany | Complaint file establishment, Exporter to the US, Foreign private label distributor, Manufacturer, Specification developer | 1 | October 24, 1991 | 0 | 0 | 0 | api.fda.gov |
| Richard Wolf GMBH | KNITTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 1 | August 27, 1997 | 0 | 0 | 0 | api.fda.gov |
| Harwood Design, Inc. | Bristol, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebumedical GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hermann Medizintechnik GMBH | FRIDINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | NEUHAUSEN OBECK Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Raimund Wenzler GMBH, Instrumenten-Manufaktur | BALGHEIM Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tekno Medical Optik-Chirurgie GMBH | TUTTLINGEN-Nendingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| medi-plus Instrumente GmbH | TUTTLINGEN-NENDINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.