Data / Medical devices / Austria / Silhouette International Schmied AG
Silhouette International Schmied AG: FDA-registered device maker in Linz Oberosterreich, Austria, 2 510(k) clearances
Silhouette International Schmied AG is registered with the FDA (registration 3008345156) in Linz Oberosterreich, Austria. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 2, 1995. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008345156
- Address
- Ellbognerstrasse 24, Linz Oberosterreich, Austria, A-4021
- Owner or operator
- Silhouette International Schmied AG (10032182)
- Roles
- Manufacturer
- First device listed
- April 16, 2010
- Registered through
- 2026
- Brand names listed
- Evil Eye, Silhouette, Silhouette Vision Sensation Panorama Lenses, neubau
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Frame, Spectacle | HQZ | 1 | Manufacturer | accessdata.fda.gov |
| Lens, Spectacle, Non-Custom (Prescription) | HQG | 1 | Manufacturer | accessdata.fda.gov |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 2, 1995 | K950519 | SILHOUETTE SUNLIMITED ADIDAS | HQY | Substantially Equivalent | Silhouette Optical , Ltd. | accessdata.fda.gov |
| September 28, 1994 | K944160 | SILHOUETTE, SUNLIMETED,ADIDAS | HQZ | Substantially Equivalent | Silhouette Optical , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Lens, Spectacle, Non-Custom (Prescription)
- All makers of Frame, Spectacle
- All makers of Sunglasses (Non-Prescription Including Photosensitive)
Updated March 2, 1995. 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.