Data / Medical devices / Valve, Prosthesis
Valve, Prosthesis (ISP): 15 FDA-registered makers in 7 countries
15 establishments in 7 countries are registered with the FDA to make Valve, Prosthesis (product code ISP, Class 1, 21 CFR 890.3420). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on November 27, 1984, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- ISP
- Device class
- 1
- Regulation
- 890.3420
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Germany | 3 |
| Sweden | 1 |
| Mexico | 1 |
| Austria | 1 |
| Bulgaria | 1 |
| France | 1 |
Makers of Valve, Prosthesis
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 |
|---|---|---|---|---|---|---|---|---|
| Jaeger Medical GmbH | HOECHBERG Bavaria, Germany | Complaint file establishment, Manufacturer | 1 | November 27, 1984 | 0 | 0 | 0 | api.fda.gov |
| Amparo Prosthetics, Inc. | West Valley City, UT, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| COYOTE O&P, Inc | Boise, ID, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cypress Adaptive, LLC | Atlantic Highlands, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fillauer Europe | JARFALLA Stockholm, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fillauer, LLC | Chattanooga, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| O And P De Mexico S.A. De C.V. | Guadalajara Jalisco, Mexico | Contract manufacturer, Foreign private label distributor, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Otto Bock Healthcare Products GmbH | Vienna Wien, Austria | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ottobock Manufacturing Bulgaria EOOD | Blagoevgrad, Bulgaria | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH | DUDERSTADT Lower Saxony, Germany | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Proteor | Dijon Cedex Cote-d'Or, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Proteor Usa | Tempe, AZ, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PROTEOR USA, Gunnison | Gunnison, UT, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STREIFENEDER ortho.production gmbH | EMMERING Bavaria, Germany | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WillowWood Global LLC | Mt Sterling, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 27, 1984. 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.