Data / Medical devices / Prosthesis, Adhesive, External
Prosthesis, Adhesive, External (GBJ): 9 FDA-registered makers in 7 countries
9 establishments in 7 countries are registered with the FDA to make Prosthesis, Adhesive, External (product code GBJ, Class 1, 21 CFR 878.3750). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on December 10, 1993, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GBJ
- Device class
- 1
- Regulation
- 878.3750
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Germany | 1 |
| Sweden | 1 |
| India | 1 |
| Spain | 1 |
| United Kingdom | 1 |
| Finland | 1 |
Makers of Prosthesis, Adhesive, External
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 |
|---|---|---|---|---|---|---|---|---|
| Amoena Medizin-Orthopadie-Technik GMBH | Raubling, Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Atos Medical AB | HORBY Skane, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Delta Molding LLC | Woodland, CA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eon Meditech Pvt. Ltd. | Surat Gujarat, India | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EarGear LLC | Eden Prairie, MN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovaciones Disras S L | Don Benito Badajoz, Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technovent Limited | Bridgend, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ten Aces Med LLC | Lake Zurich, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teampac Oy | Liljendal Etela-Karjala, Finland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 10, 1993. 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.